Demographic data supporting FDA authorization of AI devices for Alzheimer disease and related dementias

JAMA

2025-07-30

(Press-News.org) About The Study: Transparency of evidence supporting Food and Drug Administration (FDA) authorization of artificial intelligence (AI)- and machine learning -based devices for Alzheimer disease and related dementias was limited, precluding effective evaluation of training and validation dataset representativeness. Disease status (i.e., dementia type and distribution), age, and sex were reported for fewer than half of devices, while race and ethnicity data were rarely disclosed, raising uncertainty about real-world generalizability and clinical accuracy in intended populations.

Corresponding Author: To contact the corresponding author, Ravi Gupta, MD, MSHP, email ravigupta@jhmi.edu.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jama.2025.12779)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

# # #

Media advisory: This study is being presented at the Alzheimer’s Association International Conference.

Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2025.12779?guestAccessKey=48ec550b-986d-48c5-ab38-2c855859a07a&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=073025

END

ELSE PRESS RELEASES FROM THIS DATE:

How the common fungus Candida albicans colonizes the gut

2025-07-30

About 80% of people have the fungus Candida albicans in their gut. Although most of the time it persists unnoticed for years causing no health problems, C. albicans can turn into a dangerous microbe that causes serious diseases in many organs, including the urinary tract, lungs and brain. Understanding how this fungus colonizes the gut is key to preventing it from becoming harmful. Working with a mouse model, researchers at Baylor College of Medicine and international collaborators have discovered unexpected factors that help C. albicans ...

How are coastal New Jersey communities communicating hazards of climate change?

2025-07-30

Recent climate-related crises — from severe storms and flooding to extreme heat — have raised new questions about how local governments communicate the risk of these crises and what they are doing to keep their citizens safe. To better understand what this communication looks like at local level, and the factors that may be shaping it, researchers from Drexel University analyzed climate resilience planning information available on the public-facing websites of 24 coastal communities in New Jersey that are contending with the effects of sea level rise. Their report, recently published in the Journal of Extreme Events, ...

AI-based breast cancer risk technology receives FDA Breakthrough Device designation

2025-07-30

A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman’s personalized five-year risk of developing breast cancer has received Breakthrough Device designation from the Food and Drug Administration (FDA). Developed by researchers at Washington University School of Medicine in St. Louis, the software has been licensed to Prognosia Inc., a WashU startup company. The system analyzes mammograms to produce a risk score estimating the likelihood that a woman will develop breast cancer over the next five years. The technology is ...

Young men with passive approach to news tend to believe medical misinformation

2025-07-30

True or false? “It is safe to take an over-the-counter medicine to help you sleep, even if you are drunk on alcohol.” “Driving while high on THC (cannabis) is safe.” “Using psychedelics is safe for everyone.” None of those statements is true. But young men who take a passive approach to news and information—consuming whatever flows over their social media transoms—were likely to believe them in a national survey conducted by Washington State ...

Announcing Zuber Lawler as a Sponsor of ARDD 2025

2025-07-30

The University of Copenhagen is excited to announce Zuber Lawler as a Sponsor of the 12th Aging Research & Drug Discovery Meeting, the world's largest conference on aging research in the biopharmaceutical industry that will transpire on August 25 - August 29, 2025 on-site at the Ceremonial Hall, University of Copenhagen, and online. “Zuber Lawler demonstrates meticulous attention to detail with a client-first mentality… They offer personalized care from highly intelligent and creative counsel… ...

Is this what 2,500-year-old honey looks like?

2025-07-30

Decades ago, archaeologists discovered a sticky substance in a copper jar in an ancient Greek shrine. And until recently, the identity of the residue was still murky — is it a mixture of fats, oils and beeswax or something else? Researchers publishing in the Journal of the American Chemical Society have reanalyzed samples of the residue using modern analytical techniques and determined that it’s likely the remains of ancient honey — a conclusion previous analyses rejected. Honey was an important substance in the ancient world, sometimes left in shrines as offerings ...

Economic evaluation of wastewater surveillance for COVID-19 testing in long-term care settings

2025-07-30

The COVID-19 pandemic has placed enormous pressure on healthcare systems and economies around the world, with particularly severe impacts on vulnerable groups like residents of long-term care facilities (LTCFs). One key lesson from the pandemic is that early detection and treatment can lower hospitalization and death rates while also cutting medical costs. Wastewater surveillance at treatment plants (WSTPs) has emerged as a low-cost and innovative method to detect outbreaks early. Many developed countries have adopted this approach, ...

Announcing Deep Origin as a sponsor of ARDD 2025

2025-07-30

The University of Copenhagen is excited to announce Deep Origin as the latest tier 3 sponsor of the 12th Aging Research & Drug Discovery Meeting, the world's largest conference on aging research in the biopharmaceutical industry that will transpire on August 25 - August 29, 2025 on-site at the Ceremonial Hall, University of Copenhagen, and online. Deep Origin is building hybrid mechanistic, physics and AI-based models that help researchers design, test, and filter therapeutics in silico – particularly for challenging disease areas such as aging. ...

Cancer cells ‘power up’ when literally pressed to the limit

2025-07-30

Cancer cells mount an instant, energy‑rich response to being physically squeezed, according to a study published in the journal Nature Communications. The surge of energy is the first reported instance of a defensive mechanism which helps the cells repair DNA damage and survive the crowded environments of the human body. The findings help explain how cancer cells survive complex mechanical gauntlets like crawling through a tumour microenvironment, sliding into porous blood vessels or enduring the battering of the bloodstream. The discovery of the ...

Huge hidden flood bursts through the Greenland ice sheet surface

2025-07-30

A huge flood triggered by the rapid draining of a lake beneath the Greenland ice sheet occurred with such force that it fractured the ice above and burst out across its surface. This phenomenon, observed for the first time in Greenland and detailed in research published today in the journal Nature Geoscience, sheds new light on the destructive potential of meltwater stored beneath the ice sheet. It reveals how, under extreme conditions, water flooding underneath the ice can force its way upwards through the ice and escape at the ice sheet surface. This phenomenon is not considered by numerical models ...

Several healthy diet patterns are associated with reduced risk of type 2 diabetes regardless of ethnicity – shows meta-analysis of more than 800,000 people

Demographic data supporting FDA authorization of AI devices for Alzheimer disease and related dementias

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: