The authors show that existing regulatory requirements for approval have so far only partially addressed many of these so-called “human factors-related risks”. This can create gaps that impact the safety and quality of care. To address these, the researchers identify seven key risks and develop practical recommendations for action that can be integrated into existing regulatory and documentation processes.

Risks in the use of AI systems

AI-based medical devices can be used in various areas of clinical environments. In radiology, for example, they assist in detecting cancer. Clinical decision support systems help select personalized therapies for patients.  AI can also support real-time monitoring and early warning systems, as well as chatbots for applications such as patient communication and software that automatically generate medical reports or summarize findings. The analysis focuses on risks that may arise in the practical use of such AI systems. These include, for example, an increased likelihood of outputs being misunderstood or misinterpreted due to the sometimes-opaque nature of AI systems. Problems can also occur when trust in the application is miscalibrated: resulting in users either relying too heavily on AI assistance or ignoring relevant recommendations. The researchers also point to the risk of automation bias: the tendency to uncritically adopt recommendations from automated systems, potentially overlooking errors or forgoing independent judgment. Additional risks include potential deskilling, technostress among users, an unchecked expansion of indications beyond the originally intended scope (indication creep), and errors related to system changes or different operating modes. Such factors can create additional burdens or unexpected failures in clinical practice – even when the technical performance of a system itself is strong.

A practical guide for manufacturers and evaluators

For their analysis, the research team evaluated existing standards on usability and safety, regulatory guidelines, alongside the scientific literature on AI in healthcare. In addition, expert discussions from the fields of clinical application, regulation, and human factors were incorporated. The result is a practical guide, that fills a gap in current standards, with seven recommendations. These are intended to support manufacturers and evaluators both before and after a product is placed on the market. The aim is to identify AI-specific risks in interaction with human users at an early stage and to address them systematically.

The framework recommends developing and deploying AI-based medical devices in a way that clearly defines the users, in which context the systems are applied, and which tasks are assigned to humans and which to the system. Furthermore, results should be presented in a way that is easy to understand, integrated into existing clinical workflows, and supplemented by training where needed as well as safe fallback options in the event of system failures. The authors emphasize the importance of continuous monitoring after market entry. Usage patterns, potential misuse, or overreliance on AI systems should be systematically observed and corrected as needed. Changes to the systems must also be communicated transparently so that work processes can be adjusted accordingly.

The recommendations are deliberately formulated in general but regulatory-aligned terms so that they can be applied to different AI-enabled medical devices and application scenarios. In a next step, the researchers aim to test and further develop their recommendations based on concrete pilot applications with AI-enabled medical devices. In the long term, human factors should be systematically considered in the regulation and evaluation of AI-based health technologies – reducing avoidable risks while supporting safe innovation in medicine.

The article was authored by researchers from TU Dresden (EKFZ for Digital Health, Chair of Industrial Design Engineering, and Faculty of Business and Economics), in collaboration with experts from the University of Oxford (United Kingdom) and Geneva University Hospital (Switzerland).

Publication

Rebecca Mathias, Anne Schmitt, Mateo Campos, Baptiste Vasey, Sebastian Lorenz, Peter McCulloch, Stephen Gilbert: Evaluation of Human Factors-Related Risks in AI-Enabled Medical Devices: A Practical Guide, NEJM AI, 2026. Link: https://ai.nejm.org/doi/full/10.1056/AIpc2501297

Else Kröner Fresenius Center (EKFZ) for Digital Health

The EKFZ for Digital Health at the Faculty of Medicine at TUD Dresden University of Technology and University Hospital Carl Gustav Carus Dresden was established in September 2019. It receives funding of around 40 million euros from the Else Kröner Fresenius Foundation for a period of ten years. The center focuses its research activities on innovative, medical and digital technologies at the direct interface with patients. The aim here is to fully exploit the potential of digitalization in medicine to significantly and sustainably improve healthcare, medical research and clinical practice.

The World Health Organization estimates that 1 in 10 medications ranging from cancer treatment to contraceptives are either fake or otherwise “substandard.” Though this primarily affects the developing world, there are also gray markets for weight-loss or anti-aging drugs in the U.S.

“Watered-down or illicit versions of drugs like Botox or popular GLP-1 inhibitors have caused serious injuries or death,” said William Grover, associate bioengineering professor at the University of California, Riverside.

In response to this problem, Grover’s laboratory has developed a fake drug detector that could be manufactured for under $30, and potentially for as little as $5. Open-source plans to build the device are detailed in a new paper in the journal Analytical Chemistry.

At its core is a low-cost infrared sensor made for use in toy robots able to follow lines drawn on paper. The researchers repurposed the sensors to instead track the rate at which pills dissolve in water.

All pills of a given drug dissolve — or should dissolve — at roughly the same rate.  Legitimate medications don’t necessarily dissolve any faster or slower than counterfeit ones. But they were made by different people at different facilities and with different ingredients, so their dissolution rates form a “fingerprint” that makes them identifiable and different from that of a fake drug.

“The theory here is that if it’s a legitimate medicine, the manufacturer made every pill identical enough that they’ll all behave roughly the same way when they dissolve,” Grover explained. “So if you test a suspect pill, and it dissolves at a different rate than the real thing, this suggests the suspect pill is counterfeit.”

While others have used dissolution rates to determine a medication’s legitimacy, Grover’s laboratory made the tests more sophisticated by creating an electronic device that converts a pill’s dissolution into a digital signature that they call a “disintegration fingerprint.”

After designing the device, the researchers sought to create a library of these fingerprints that could be used to identify a suspect pill. The group tested over 30 different medications ranging from antibiotics and vitamin supplements to prescription opioids and over-the-counter painkillers. They found that 90% of these pills could be correctly identified using the fingerprinting method.

The group also tested whether their technique could distinguish name-brand and generic versions of the same drug.

“We took Bayer aspirin pills and drug-store-brand aspirin — these are basically identical medicines with the same active ingredient and very similar inactive ingredients,” Grover said, “but when ran through our tests, we could easily tell the difference between the two products.”

The research team even recruited their friends and family to collect samples of drug products from across the U.S. and Canada. They found that pills of the same product typically have similar disintegration fingerprints regardless of where they were purchased. However, some manufacturers make slightly different versions of products for different countries and fingerprinting successfully distinguished U.S. and Canadian versions of a product.

Though there are high-quality pharmaceuticals widely available in the U.S., the CDC warns that there is a public health risk for people ordering what they believe to be prescription medications from disreputable online pharmacies. These medications are frequently found to be fakes.

Other times, a medication could contain irregularities because of manufacturing mistakes. “A facility could get a drum of mislabeled ingredients that can get incorporated into the medicine,” Grover said. “But even an honest error can lead to death.”

In the future, Grover would like to use this method to detect fake antimalarial drugs. These are drugs that treat malaria, a major cause of death in many tropical regions.  Malaria is treatable with the right medications.

“Unfortunately, bad actors know they can make money preying on the need for antimalarials. They sell pills that have the same packaging as authentic antimalarials, but  don’t contain the active ingredients,” Grover said. “If someone gives these pills to their child, they won’t cure their infection.”

Grover hopes to get his tool into the hands of those who can use it to fight fake antimalarials and other fake drugs.

“I can’t imagine a more despicable person than someone who would sell fake medicine to a child. I hope our work makes those criminals’ lives a little harder.”

Image: By counting the particles formed when a pill dissolves in a water-filled cup, the team’s device can identify fake medications.

View more Credit: William Grover/UCR

The researchers in the School of Pharmacy have created a customizable wound scaffold that delivers natural, biodegradable antibacterials over time to encourage healing. Researchers Michael Repka, distinguished professor of pharmaceutics and drug delivery; Sateesh Vemula, postdoctoral researcher; and doctoral candidate Nouf Alshammari published their results in the European Journal of Pharmaceutics and Biopharmaceutics.

“People with limited mobility or diabetes often have wounds with reduced oxygen supply,” Vemula said. “This can slow the body’s normal repair process and make wounds more likely to become long-lasting, while also increasing the chance that bacteria can grow and lead to infection.”

Chronic wounds, including diabetic ulcers and pressure sores, can linger for months or even years.

Repka and his team are 3D-printing a breathable, patch-like structure that can be placed over the wound. The patch is made using chitosan – a natural material found in crustaceans, insects and fungi – along with plant-derived antimicrobials that help fight germs. Chitosan helps accelerate the growth of skin cells while reducing inflammation and preventing infection.

This structure acts as a scaffold, encouraging growth while also protecting the wound from outside sources of infection or contamination.

“A lot of bandages are made with organic solvents, which actually hurt the wound-healing process, especially when applied intimately on the wound,” Repka said. “With the materials and technique we’re using, you don’t have organic solvents.

“We’re also not using traditional antibiotics over a long period of time, because that can often cause the bacteria to become resistant. That’s the advantage of using natural products.”

Using a 3D printer to create the scaffold means that the patch can be tailored to fit any wound on any part of the body.

“The materials we used are also biodegradable,” Alshammari said. “With time, the scaffold is going to be absorbed into the skin. And it’s an inactive material, so we don’t have to worry about side effects or toxic residuals.”

Being biodegradable also means that if the material is applied to wounds inside the body, health care professionals don’t have to make a second incision to remove it, Vemula said.

The technology can be applied to other types of wounds where a traditional bandage would not be suitable, the Ole Miss researchers said.

“Depending on what kind of wound it is, a regular bandage might work well and this wouldn’t be necessary,” Repka said. “But there are a lot of applications for this technology. These could be printed in the field for, say, military applications.

“If you have a generator that can run these 3D printers, you can print the scaffold you need based on what kind of wound has occurred.”

Before the scaffold can be used clinically, it will need further testing and review by the Food and Drug Administration.

“The goal is translating this from research to patients,” Repka said.

Image: Michael Repka, distinguished professor of pharmaceutics and drug delivery, works with a 3D-printed medical device in his lab in Shoemaker Hall. Repka’s latest research shows that 3D-printed wound scaffolding could aid in healing chronic wounds. 

View more Credit: Photo by Thomas Graning/Ole Miss Digital Imaging Services

A new study, published in the March 9 online issue of npj Health Systems [https://doi.org/10.1038/s44401-026-00077-0], suggests that the answer depends less on the AI itself and more on how it’s designed.

The investigators found that health care AI systems work far better when tasks are distributed among multiple specialized AI “agents”—software systems that can perform complex tasks, learn, and adapt—rather than relying on a single, all-purpose agent. This multi-agent approach kept performance steady even as demands increased, while dramatically reducing computing costs and delays, say the investigators.

“For health care organizations, our findings point to a smarter way to use AI,” says senior study author Girish N. Nadkarni, MD, MPH, Barbara T. Murphy Chair of the Windreich Department of Artificial Intelligence and Human Health, Director of the Hasso Plattner Institute for Digital Health, Irene and Dr. Arthur M. Fishberg Professor of Medicine at the Icahn School of Medicine, and Chief AI Officer of the Mount Sinai Health System. “By assigning different tasks, such as finding patient information, extracting data, or checking medication doses, to specialized AI agents, systems can run faster and more reliably while keeping costs under control. Ultimately, this kind of design could help health care teams spend less time on administrative work and more time focusing on patients.”

As part of the study, the researchers compared two approaches to clinical AI: a single system responsible for handling many different clinical tasks, and a coordinated network of specialized AI agents overseen by a central “orchestrator.” Using state-of-the-art language models, the team evaluated performance across common clinical functions, including information retrieval, data extraction, and medication dosing calculations—under simulated real-world conditions involving up to 80 simultaneous tasks.

“What we found is that AI systems behave a lot like people,” says study lead author Eyal Klang, MD, formerly with the Icahn School of Medicine. “When you ask one system to do too many different things at once, performance suffers. But when one orchestrator agent divides the work among specialized agents, the system stays accurate, responsive, and far more efficient, even under heavy demand.”

The coordinated multi-agent system maintained superior accuracy levels while using far fewer computing resources, up to 65 times fewer, than a single-agent design. The study simulated real clinical “traffic,” where many types of tasks arrive at once and compete for attention, the investigators say.

“Our findings show that smart coordination is not just a technical preference,” Dr. Klang says. “It can make the difference between an AI system that continues to function smoothly and one that begins to break down when it is exposed to the pressures of real clinical workloads.”

Next, the research team plans to test these coordinated AI systems directly in clinical settings, using real-time patient data. If successful, this approach could help shape how hospitals and health systems scale AI in the future, helping them handle peak workloads without sacrificing quality or safety.

The researchers emphasize that the gains are not automatic: even sophisticated AI can fall short when systems are poorly designed or implemented. “Health care does not operate one task at a time,” Dr. Nadkarni says. “Hospitals face constant, overlapping demands, especially during busy periods. Our findings show that the future of health care AI is not a single super-intelligent system, but a coordinated team of focused agents that work together to scale safely, control costs, and support real clinical operations.”

“When a single agent handles everything, you can’t trace where it went wrong. With the orchestrator, every step is logged, which tool was called, what it returned, and how the answer was assembled. At 80 simultaneous tasks, the single agent dropped to 16 percent accuracy while burning 65 times more compute—and you’d have no way to figure out why. That kind of transparency isn’t optional in medicine,” says second author Mahmud Omar, MD, a visiting researcher in the Windreich Department. “This matters more now than ever—agentic AI is no longer a research concept. Tools like OpenAI’s operator mode, Claude’s Cowork, and similar platforms are putting autonomous agents directly in the hands of clinicians and patients. As that adoption accelerates, the architecture behind these systems has to be auditable from the start.”

The paper is titled “Orchestrated multi agents sustain accuracy under clinical‑scale workloads compared to a single agent.”

The study’s authors, as listed in the journal, are Eyal Klang, Mahmud Omar, Ganesh Raut, Reem Agbareia, Prem Timsina, Robert Freeman, Lisa Stump, Alexander Charney, Benjamin S. Glicksberg, Girish N. Nadkarni.

This work was supported  in part by the Clinical and Translational Science Awards (CTSA) grant UL1TR004419 from the National Center for Advancing Translational Sciences. Research reported in this publication was also supported by the Office of Research Infrastructure of the National Institutes of Health under award number S10OD026880 and S10OD030463.

For more Mount Sinai artificial intelligence news, visit: https://icahn.mssm.edu/about/artificial-intelligence.

Their findings were published last month in Nature Chemistry (https://www.nature.com/articles/s41557-025-02011-7).

For nearly thirty years, researchers who tried to control when and where plastics harden focused on designing special “sleeping” catalysts, molecules that stay dormant until they are triggered by light, heat, or another signal. These catalysts are often sensitive, expensive, and difficult to handle.

The BGU team turned this logic on its head, as PhD student Nir Lemcoff, one of the lead authors on the paper, described, “This work demonstrates a new way of thinking about a general problem in polymer science and will hopefully inspire scientists in the field to look at the challenges in their own work with a fresh point of view”.

Instead of trying to put the on/off switch in the catalyst, they hid it inside the plastic building blocks themselves, creating so-called “latent monomers.” These are stable liquid building blocks that remain inactive for weeks. They then “snap” into a solid plastic-like material only when exposed to light or gentle heating.

These new latent monomers are built from small molecules called norbornadienes. Norbornadienes can be opened and linked into long chains by a standard plastic-making method called ROMP (ring-opening metathesis polymerization). When UV light is shined on them, they change into a different form called quadricyclane, which is basically the “off” state: it is inactive and does not build chains. Later, gentle heating with tiny gold nanoparticles switches quadricyclane back “on” to the reactive norbornadiene, so the chain-building can start again on demand. Because chemists can easily make many different norbornadienes, this switchable system could give rise to hundreds of new plastic-like materials, including some that are very hard to make with existing methods.

“Instead of a ‘sleeping’ catalyst, we created ‘sleeping’ building blocks of the material itself,” explains Prof. Yossi Weizmann of the Department of Chemistry at Ben-Gurion University, who led the study. “The mixture can sit quietly on the shelf for weeks and will snap together into a solid only when you shine light on it or warm it up. That kind of on-demand, light-driven curing could make industrial production, printing, and repair processes safer, simpler and more energy-efficient.”

The new liquids contain three key ingredients:

• Building blocks that can link together into long plastic-like chains
• A standard industrial catalyst that drives the chain-forming reaction
• Tiny gold nanoparticles that act as microscopic heaters when illuminated with near-infrared light

In their “sleeping” state, the latent monomers are locked in a form that does not react, even though the catalyst is already present. When the researchers shine light on the gold nanoparticles, they heat up their immediate surroundings and flip the monomers into an “active” form that quickly links into a solid material. The same switch can also be thrown by conventional heating, but not as efficiently.

Since nothing happens until the trigger is applied, manufacturers could in principle:

• Store and ship a ready-to-use liquid formulation for weeks without it thickening or hardening
• Fill, coat, or print parts first, and only then turn on curing in selected regions using light patterns or masks
• Reduce waste and energy use by avoiding the need to constantly mix fresh batches or heat entire volumes for long periods

The study also shows that this idea of switchable building blocks can do much more than simply turn a reaction on and off. By mixing building blocks that are active from the start with others that stay asleep until they are heated, the team can make plastics whose chains have two different sections, which gives materials with combined properties in one product. They can also first create a soft material that is easy to shape and later lock it into a tougher and more durable solid, all in a single process.

Prof. Weizmann is a member of the Zuckerman STEM Leadership Program.

Additional researchers on the project, all from Ben-Gurion University of the Negev, include Ronny Niv from Prof. N. Gabriel Lemcoff’s group who are joint first authors on the paper, as well as Keren Iudanov from the Lemcoff lab, and Gil Gordon, Aritra Biswas, Uri Ben-Nun and Ofir Shelonchik from the Weizmann lab.

The work was supported by the Israel Science Foundation (ISF, grant no. 2491/20) and the United States–Israel Binational Science Foundation (BSF, grant no. 2020144).

Image: Prof. Yossi Weizmann

View more Credit: Amit Paor/BGU

IVF patients must inject themselves with hormones daily at specific times in the weeks leading up to egg retrieval, a process that can be physically and emotionally taxing.

The team’s new system uses a hydrogel microneedle patch filled with specially engineered nanoparticles that hold and release a key IVF hormone, leuprolide, when stimulated by near-infrared light. The light can be programmed to release the drug at the desired time.

Toward personalized, programmable dosing

Current light-triggered drug delivery systems often release foreign materials into the body, posing regulatory and safety challenges.

“This is the first time that we were able to show light-triggered drug release from a nanoparticle-microneedle composite without releasing any foreign substance into the body,” said Marta Cerruti, a materials engineering professor and senior author of the study in Small.

The researchers say this key advance could accelerate clinical translation, as the delivery system leaves no nanoparticles behind in the skin.

In building their system, the team first optimized how many hormone-bearing nanoparticles could be incorporated into each microneedle without weakening its ability to penetrate skin. They then tested whether the light trigger could release the hormone into a porcine skin model over two hours. Finally, they demonstrated that even a short five-minute pulse of light released measurable levels of leuprolide into the skin, bloodstream and organs of a live rat.

“The light can also be programmed to release the drug at the specific time the drug is needed, which could differ for each individual,” said Tam, the PhD student in Cerruti’s lab who was also the lead author on this study.

“IVF success rates are at best 30 per cent, even for the youngest women. The hope is that if you take out the human error with injecting yourself and deliver the drug at times optimized for each patient, you could potentially see this success rate go up,” she said.

Beyond IVF

For IVF patients, the technology could make treatment easier, less painful and potentially more effective, but the system could also help anyone who relies on daily injections, including people with diabetes or multiple sclerosis.

Because no nanoparticles enter the body, the researchers say the platform has a clearer pathway to clinical adoption than previous systems. More work is planned to refine dosing, explore hormone release profiles and investigate commercial possibilities.

About the study

“Upconverting Nanoparticle-Loaded Microneedles for Near-Infrared Responsive Delivery of Gonadotropins to Increase Success of In-Vitro Fertilization” by Vivienne Tam, Rusvir Trana, Alfonso Nieto-Arguello, Ore-Oluwa Olasubulumi, Samuel Babity, Artiom Skripka, Fiorenzo Vetrone, Davide Brambilla, and Marta Cerruti, was published in Small.

Funding

This research was supported by Natural Sciences and Engineering Research Council (NSERC) and Vanier Canada Graduate Scholarships.

A new scientific statement from the American Heart Association, Cuffless Devices for the Measurement of Blood Pressure, details more information that supports the recommendations in the recently published 2025 AHA/ACC High Blood Pressure Guideline, which recommended against using cuffless blood pressure devices for diagnosis or treatment until they demonstrate greater precision and reliability. This scientific statement provides an overview of available cuffless technologies and their potential future applications, while highlighting the notable limitations that need to be addressed before these devices can be used safely in clinical practice or as home monitoring devices.

According to the American Heart Association, nearly half of U.S. adults, about 122 million people, have high blood pressure (≥130/80 mm Hg), also known as hypertension. High blood pressure is the #1 modifiable risk factor for cardiovascular disease, including heart attack, stroke and heart failure, as well as kidney disease, cognitive decline and dementia. High blood pressure is a leading cause of death in the U.S. and around the world, affecting an estimated 1.4 billion adults, two-thirds of whom live in low- and middle-income countries.

“Cuffless blood pressure devices are easy to use, convenient and capable of frequent or continuous monitoring, potentially providing insights into blood pressure changes during daily life and sleep,” said Chair of the scientific statement writing group Jordana Cohen, M.D., M.S.C.E., FAHA, an associate professor of medicine and epidemiology at the Perelman School of Medicine at the University of Pennsylvania. “However, the speed of commercialization has outpaced the science.”

“We developed this scientific statement to address growing confusion among clinicians and patients about how these devices work, what their readings mean and whether they can be trusted for medical decision-making,” Cohen said.

Variety of cuffless blood pressure devices available

The number and type of new wireless, personal devices available that state they are capable of measuring blood pressure have increased significantly over the past decade. These technologies include smartwatches, rings, patches and smartphone-based sensors that use light or force signals to estimate blood pressure. The devices differ by how they detect cardiovascular signals, such as photoplethysmography (using a sensor to estimate blood pressure by how much light is absorbed) or tonometry (a sensor that measures arterial force waves), how those signals are processed, and whether they require calibration with a conventional arm cuff blood pressure monitor. Some cuffless devices also incorporate demographic information such as the user’s age, sex, height or weight.

Although some devices are cleared by the Food and Drug Administration (FDA), careful consideration and continual monitoring of the measurement device’s validation status is still essential before clinical use. FDA clearance for a blood pressure device does not require formal accuracy testing under a standardized protocol. Therefore, regulatory clearance does not guarantee measurement accuracy. Up to 80% of all blood pressure devices sold globally have never undergone formal validation testing for accuracy, with cuffless devices showing even lower rates of validation.

Limitations of cuffless blood pressure devices

With these rapid technologic advances, device developers, clinicians and the public have struggled to keep up with methods of testing device accuracy, understanding the nuances of how different devices operate and what they are designed to estimate (blood pressure or change in blood pressure), and interpretation of the massive amount of data. Cuffless devices often produce a high volume of readings, many obtained in settings where blood pressure measurements were not previously performed, such as during sleep and physical activity. The clinical relevance of this data remains uncertain.

Future research is needed to determine how cuffless device readings correlate with cardiovascular outcomes, such as heart attack or stroke, before these tools are used in health care settings. Without established thresholds or outcome-linked validation, frequent measurements may lead to confusion, false reassurance or unnecessary alarm for both the public and health care professionals.
The statement writing group emphasizes that cuffless blood pressure devices should not be used at this time to diagnose, track or treat high blood pressure. Many personal wearable devices have not been validated (proven to be accurate and reliable) for real world use, such as during exercise, sleep, daily activity or after taking medication that affects blood pressure. In addition, variables like arm position, skin color and how recently the device was calibrated, can also affect the results and contribute to inaccurate blood pressure measurements.

“Without proper validation, readings from cuffless blood pressure device are not reliable sources to inform treatment decisions or evaluate interventions. Patients may receive incorrect diagnoses or inappropriate medication adjustments based on inaccurate data,” Cohen said.

Considerations for integrating cuffless devices into care

• Standardized validation needed for clinical use: More research and evaluation are needed to prove these devices to be accurate and meet the same criteria as cuffed blood pressure devices. The testing standards will also need to reflect how these devices are used, particularly after taking medications that affect blood pressure, while exercising, sleeping or going about daily life. More research is needed to assess accuracy, long-term performance and real world utility.

• Accuracy, access and affordability must be prioritized: If validated, cuffless technologies could expand hypertension screening, diagnosis and treatment among people in under-resourced communities. Developers of these devices must address potential inaccuracies related to skin color as well as issues related to connectivity and affordability.

• Transparency and privacy protections are critical: Manufacturers must disclose how algorithms generate readings, calibration frequency and how patient data are stored, shared and protected. Devices must clearly indicate whether readings reflect absolute blood pressure or change relative to calibration to avoid misinterpretation.

“Cuffless blood pressure devices have the potential to transform hypertension care when their accuracy and reliability improve. Clear standards and coordinated efforts in research, regulation and public education are essential to help ensure that innovation enhances, rather than compromises, cardiovascular care,” Cohen said.

“If you currently have a smart watch, ring or other cuffless technology you are using to monitor your blood pressure, make sure your doctor is aware that any home readings you share are from this type of device and talk to them about using a validated device instead for any readings that may be used for hypertension diagnosis or treatment management,” she added. A list of validated blood pressure devices is available at validatebp.org.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension; the Council on Cardiovascular and Stroke Nursing; the Council on Cardiovascular Surgery and Anesthesia; and the Council on Clinical Cardiology. American Heart Association scientific statements promote greater awareness about cardiovascular diseases and stroke issues and help facilitate informed health care decisions. Scientific statements outline what is currently known about a topic and what areas need additional research. While scientific statements inform the development of guidelines, they do not make treatment recommendations. American Heart Association guidelines provide the Association’s official clinical practice recommendations.

Co-authors are Vice Chair Tammy M. Brady, M.D., Ph.D.; Rushelle L. Byfield, M.D., M.S.C.E.; Shakia T. Hardy, Ph.D., FAHA; Stephen P. Juraschek, M.D., Ph.D., FAHA; Nancy Houston Miller, R.N., B.S.N., FAHA; Ramakrishna Mukkamala, Ph.D.; Dean S. Picone, Ph.D.; Robert H. Thiele, M.D.; and Eugene Yang, M.D., M.S. Authors’ disclosures are listed in the manuscript.

The Association receives more than 85% of its revenue from sources other than corporations. These sources include contributions from individuals, foundations and estates, as well as investment earnings and revenue from the sale of our educational materials. Corporations (including pharmaceutical, device manufacturers and other companies) also make donations to the Association. The Association has strict policies to prevent any donations from influencing its science content and policy positions. Overall financial information is available here.

Additional Resources:

• Available multimedia is on right column of release link.
• After Dec. 11, 2025, view the manuscript online.
• American Heart Association news release: New high blood pressure guideline emphasizes prevention, early treatment to reduce CVD risk (Aug. 2025)
• American Heart Association news release: Equitable access to digital technologies may help improve cardiovascular health (April 2025)
• American Heart Association news release: Only 1 in 7 online health images show proper technique to accurately measure blood pressure (Sept. 2025)
• American Heart Association news release: Heart disease remains leading cause of death as key health risk factors continue to rise (Jan. 2025)
• American Heart Association health information: High Blood Pressure and High Blood Pressure Resources
• Follow American Heart Association/American Stroke Association news on X @HeartNews
• Follow news from the American Heart Association’s Hypertension journal @HyperAHA

3D-printed doses of melatonin 1mg cost approximately half as much as the same doses prepared by manual encapsulation, according to an economic evaluation by Lena Lemierre (MB Therapeutics & University of Montpelier) and colleagues.

A study compared two hospital-based manufacturing methods for personalised oral dosage forms – semi-solid extrusion (SSE) 3D printing and traditional capsule compounding.  Resource inputs were calculated for preparation of 600-unit batches by each method. The 3D printing process relied on semi-solid extrusion of an industrially validated pharmaceutical cartridge, followed by drying within the printer (MED U PROD 1.0 ® – MB Therapeutics). Manual capsule preparation was carried out using a 300-capsule filling plate.

The costs for each dose were €1.55 (capsules) versus €0.72 (printed oral doses). The staff time required was: 35 min for analysis of printed forms (mass control only), versus 4 h 30 min for capsules (mass and content uniformity testing). HPLC analysis accounted for a large proportion of the cost of the capsules.

The authors concluded that the results demonstrated the potential of SSE 3D printing as a faster and more cost-effective alternative for hospital manufacturing of personalised oral dosage forms. The significant reduction in production time, particularly during analytical phases, enables more efficient use of human resources.

Lemierre L. et al. Techno-Economic Comparison Between Semi-Solid Extrusion 3D Printing of Oral Forms and Capsule Compounding in a Hospital Setting. Short communication. GERPAC Congress 2025

Photo – Lena Lemierre

In the first Cochrane review on the topic, the evidence suggests that switching to oral nicotine pouches from smoking reduces exposure to harmful substances, “which is what we would expect to find,” says senior author Jamie Hartmann-Boyce, assistant professor of health policy and management at the School of Public Health and Health Sciences and an editor for Cochrane, the global health research nonprofit based in the United Kingdom.

Because the Cochrane team only found four small studies that were appropriate for their review, the evidence is not yet clear on whether oral nicotine pouches can help people quit smoking or vaping. But the foundation now exists for Hartmann-Boyce and team to continue their investigation. Their ongoing Cochrane reviews have revealed the best evidence-based ways to quit both vaping and smoking.

“Other nicotine products, like patches, gums, and nicotine vapes, are definitely beneficial for helping people quit smoking,” says Hartmann-Boyce, a leader in tobacco health policy and management in the U.S. “We knew that we weren’t going to have that many studies of pouches in this review when we published the first time, but we also know there are loads in the pipeline, and we hope to regularly update this as those new studies come out. We’ve given ourselves a platform to collect that data and integrate it quicker than we would have been able to before.”

About the size of a tea bag, oral nicotine pouches contain nicotine powder and flavorings, but no tobacco leaf. The pouches are marketed as a smokeless alternative to tobacco products and occasionally as a way to reduce or quit smoking.

Unlike nicotine gum, patches, lozenges, nasal sprays and inhalers, the nicotine pouches are not FDA-approved smoking cessation aids. But earlier this year, the FDA approved the marketing of 20 Zyn nicotine pouches in the U.S., concluding that the evidence showed it offered “greater benefits to population health than risks.”

It was the first oral nicotine pouch to be so approved in the U.S., a significant FDA decision, Hartmann-Boyce notes. “An inherent argument behind the decision for these new products to enter the market is that they have the potential to move people away from smoking,” she says.

“From an academic perspective, one of the most interesting things about oral nicotine pouches is that for a long time, we have been promoting nicotine replacement therapies, like patches and gums, to help people quit smoking. The World Health Organization lists them as an essential medicine. They are a critical tool within public health, and it’s currently difficult to come up with a compelling, detailed description of why we think the risks of oral nicotine pouches—if well-regulated—would be meaningfully different than nicotine replacement therapy to an individual user.”

The pouches are placed between the lip and gum, which allows nicotine to be absorbed through the mouth. They appear similar to snus, a Swedish oral pouch filled with ground-up tobacco leaves and flavorings. The user doesn’t need to spit when using either oral nicotine pouches or snus.

“So in the same way vaping is different from smoking, because it doesn’t involve tobacco leaf, oral nicotine pouches are different from snus,” Hartmann-Boyce says. “Snus isn’t going to increase your risk of lung cancer, but it is going to increase your risk of mouth cancer, throat cancer and tongue cancer because of the tobacco leaf and chemicals in it.”

She adds that rates of smoking and smoking-related disease and death have gone down significantly in the countries that allow snus. “So, there’s certainly a harm-reduction element in thinking about non-combusted tobacco and nicotine products.”

Hartmann-Boyce notes that for people who don’t use any nicotine products, it’s best not to start. Nicotine is highly addictive, and the risks of new products are not yet well understood, particularly in people who don’t have a history of smoking.

“But it is rational, if you are someone who is addicted to smoking, to switch to using an alternative nicotine product if you can’t quit completely,” she says.

Type 2 diabetes affects more than 72 million people in India. While lifestyle interventions have shown promise for diabetes management in Western populations, limited data exists on their effectiveness in India, where genetic and lifestyle factors place the population at higher risk.

In the new study, researchers analyzed data from 2,384 adults with T2D who enrolled in a one-year online intensive lifestyle intervention program at the Freedom from Diabetes Clinic in India between May 2021 and August 2023. The intervention, provided by a six-member care team through a mobile application, included a personalized plant-based diet, structured physical activity, group therapy and individual psychological counseling, and medication management.

Overall, 744 participants (31.2%) achieved diabetes remission, defined as maintaining glycated hemoglobin (HbA1c) levels below 48 mmol/mol for at least three months without glucose-lowering medications. The remission group showed significantly greater improvements than the non-remission group in weight (8.5% vs. 5.2% reduction), body mass index (8.6% vs. 5.2% reduction), HbA1c (15.3% vs. 12.4% reduction), fasting insulin (26.6% vs. 11.4% reduction), and insulin resistance (37.3% vs. 19.7% reduction). People under 50 years of age, with higher BMI, no prior medication use, and a shorter duration of diabetes (<6 years) were most likely to achieve remission.

The study was limited by its retrospective design and lack of a control group. Because the program required a subscription and participants who lacked follow up data were excluded from the analysis, there may have been selection biases. However, the authors conclude that a significant proportion of individuals with T2D can achieve remission through a comprehensive, culturally adapted lifestyle program.

The authors add: “Our research demonstrates that nearly one-third of individuals with type 2 diabetes can achieve remission through a scientifically designed, culturally tailored, and structured lifestyle intervention. This represents the first large-scale evidence from India highlighting the potential of intensive lifestyle modification in achieving type 2 diabetes remission.”

http://plos.io/4nERyVq

Citation: Tripathi P, Kadam N, Kathrikolly T, Tiwari D, Vyawahare A, Sharma B, et al. (2025) Type 2 diabetes remission and its predictors in an Indian cohort: A retrospective analysis of an intensive lifestyle intervention program. PLoS One 20(10): e0333114. https://doi.org/10.1371/journal.pone.0333114

Author countries: India

Funding: The author(s) received no specific funding for this work.

The study is one of the first to systematically evaluate the accuracy of online images depicting blood pressure measurements on major stock photo websites based on the 2023 International Consensus on Standardized Clinic Blood Pressure Measurement.

“We expected that about 50% of images would be accurate, however, our findings were worse than expected,” said lead author Alta Schutte, Ph.D., a professor of cardiovascular medicine at the University of New South Wales Sydney, and co-lead of the cardiovascular program at The George Institute for Global Health in Australia. “Because people tend to remember images better than words — a phenomenon known as the picture-superiority effect — inaccurate visuals could have serious public health consequences.”

Nearly half of all adults in the U.S. have high blood pressure, according to the American Heart Association. (From 2017 to 2020, 122.4 million adults in the U.S., or 46.7%, had high blood pressure; source: American Heart Association’s 2025 Heart Disease and Stroke Statistics)

”More people are checking their blood pressure at home. But because of the inaccurate depictions online – even on reputable websites – it is very likely that people who look for information on the internet about blood pressure will see these images and may use the incorrect technique at home. If this happens, people will get blood pressure readings that are either too high or too low, which can lead to wrong conclusions about their blood pressure and possibly too much or too little treatment when these blood pressure measures are shared with their health care team,” Schutte said.

The analysis found:

• Only 14% of more than 1,000 images depicting adults having their blood pressure measured were accurate.
• Deviations from clinical guidelines that contributed to photo inaccuracy included:
  • the individual’s back was not supported (73%);
  • the whole forearm was not resting on a flat surface or table (55%);
  • using a manual self-pumping device instead of an electronic or battery-operated upper-arm device (52%);
  • feet were dangling rather than flat on the floor (36%);
  • the health care professional (23%) and patient (18%) were talking while taking the measurement;
  • mid-arm was not at heart level (19%);
  • people had their legs crossed (13%);
  • the patient was not sitting (5%); and
  • the blood pressure cuff was placed over clothing (12%) rather than the bare arm.
• 25% of images showing self-measurement of blood pressure at home were accurate compared to only 8% of images depicting blood pressure measurements in a physician’s office, health care facility or hospital.
• Images depicting blood pressure measurements taken by the patient themselves or another person were 6 times more likely to show accurate techniques compared to images showing blood pressure measured by a health care professional.

“There have been many interesting studies about errors in blood pressure measurement and the blood pressure effect of such errors, for example, if the cuff on the upper arm is not held at heart level. This is the first evaluation of publicly available images of blood pressure measurement to highlight the problem with inaccurate images,” Schutte said.

“It is important for people to understand how to measure their blood pressure correctly. Inaccurate readings in clinics are also a very common problem. We want everyone to know how health care professionals should take blood pressure measurements so they can identify any mistakes if the procedure is not followed correctly,” she said.

Chair of the American Heart Association’s 2025 high blood pressure guideline writing committee released last month, Daniel Jones, M.D., FAHA, said, “This study highlights the importance of using accurate images to demonstrate the proper technique for measuring blood pressure. Home blood pressure monitoring is recommended for patients to help confirm an office diagnosis of high blood pressure and to monitor, track progress and tailor care as part of an integrated care plan.” Jones, who was not involved in this study, is also a past volunteer president of the American Heart Association (2007-2008) and currently dean and professor emeritus of the University of Mississippi School of Medicine.

The American Heart Association has resources to help people learn proper blood pressure measurement techniques.

The study has several limitations. Some images were incomplete; for instance, less than a quarter of them showed whether the person had their feet crossed or flat on the floor. If these details were clear, it might affect accuracy levels. Although the included photos were not penalized based on features that were not visually assessable, the findings may be affected. Additionally, the stock images used in this study were probably not created with the International Consensus Guidelines in mind. So, any errors found likely do not stem from an intentional misrepresentation of proper technique, yet these are the images that are typically used by the media and website developers.

Study background and details:

• The analysis used a Google search conducted on July 22, 2024, to identify a comprehensive list of 11 major online stock photo sites (123rf, Adobe Stock, Alamy, Bigstockphoto, Dreamstime, Flickr, Freepik, Getty Images, iStock, Pikwizard and Shutterstock).

• The first 100 photos from each online stock photo site were downloaded for further screening. Stock photo sites with more than 10% duplicate images were excluded. Cartoon or fictional images, AI-generated images or photos without people were also excluded.

• Of 121,000 images, 1,106 photos identified with the search term “blood pressure check” in adults were each reviewed by two reviewers. Overall, about 63% of the images were in a physician’s office or hospital, while about 37% showed home blood pressure monitoring in a home setting.

• Blood pressure measurements were performed by a health care professional in 72.8% of the photos, 24.5% were done by the patient and 2.7% were taken by other people.

• Conflicts (reviewers not agreeing) of each online image were resolved in two stages. First, two reviewers independently examined the stock photos, then met as a group to discuss the screening criteria and determine if the image accurately depicted correct blood pressure measuring techniques. Blood pressure measurements depicted in the images were checked for accuracy based on: whether the patient or the person taking the measurement was talking or laughing; the patient’s position: sitting, whether their whole forearm was resting on the table, mid-arm at heart level, back supported by a chair, legs uncrossed, and feet flat on the floor; the type of blood pressure measurement device: an electronic upper-arm device instead of a manual device; and the blood pressure cuff: placed on a bare arm.

“We have noted photos with wrong techniques on the websites of major health organizations and universities. We urge these organizations, media outlets, stock photo creators, web developers, medical journalists, and researchers to take a closer look at their online images. They should check that all images show how to measure blood pressure accurately and represent the proper techniques to reduce the likelihood of incorrect blood pressure readings at home and in clinical settings,” Schutte said.

Co-authors, disclosures and funding sources are listed in the manuscript.

Studies published in the American Heart Association’s scientific journals are peer-reviewed. The statements and conclusions in each manuscript are solely those of the study authors and do not necessarily reflect the Association’s policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. The Association receives more than 85% of its revenue from sources other than corporations. These sources include contributions from individuals, foundations and estates, as well as investment earnings and revenue from the sale of our educational materials. Corporations (including pharmaceutical, device manufacturers and other companies) also make donations to the Association. The Association has strict policies to prevent any donations from influencing its science content and policy positions. Overall financial information is available here.

The gel formula, called NORel, significantly outperformed an alcohol-based sanitizer by maintaining effective antimicrobial activity as long as two hours after application. The alcohol-based gels the researchers tested had long evaporated and taken their antimicrobial agents with them by that time. Typical hand sanitizers evaporate shortly after application and lose much of their microbe-killing power within 30 to 60 minutes.

NORel’s potential as a long-lasting, powerful hand hygiene solution is particularly promising for high-risk environments such as hospitals, clinics and long-term care facilities.

The new gel relies on the disinfecting abilities of nitric oxide, a molecule that naturally occurs in the body and plays a critical role in helping fight off infections.

“Regular hand sanitizers with alcohol in them do a pretty good job at killing bacteria when you apply them initially,” said Elizabeth Brisbois, lead author of the study and an associate professor in the UGA College of Engineering. “We showed that the nitric oxide persists on the skin for a longer period of time, so it’s kind of an extended protective effect. That was the most exciting result.”

New sanitizing gel performs as well as alcohol-based sanitizer currently on the market

Fortified with antimicrobial and moisturizing ingredients like ethanol, tea tree oil and glycerin, NORel gel harnesses the proven antimicrobial benefits of nitric oxide in other skin-related applications, such as wound healing and acne treatment.

“We started thinking more about what exactly hand sanitizers are made of,” Brisbois said, “and how we could incorporate nitric oxide into a typical hand sanitizer.”

Much like other NO applications Brisbois and her colleagues have studied, the formula holds promise for use as a hand sanitizer in health care settings, preventing associated infections for both health care professionals and the patients they treat.

The gel’s antimicrobial activity is on par with commercial, alcohol-based sanitizers containing 62% ethyl alcohol.

Next up? Testing the gel against pathogens like COVID-19, which shut down the globe in 2020, as well as improving the gel’s shelf life.

“In this initial project, our focus was on formulating the hand sanitizer and evaluating its effectiveness against bacteria commonly associated with medical device infections,” Brisbois said. “Further research to improve the formulation chemistry and assess its efficacy against other infectious agents, such as viruses and additional types of fungi, as well as improving its stability at room temperature, would help advance this technology.”

Published in Biomaterials Science, the study was co-authored by Manjyot Kaur Chug, Gabrielle Aluisio, Cole Bousquet, Mark Garren, Yun Qian and Joseph H. Campbell. It was funded by the National Heart, Lung and Blood Institute, a unit of the National Institutes of Health.