The US FDA launches a pilot using AI and cloud computing that gives it a “direct data feed” to real-time clinical trial data, aiming to speed up drug approval
The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce …
The US FDA qualifies the first AI drug development tool, AIM-NASH, to help doctors assess MASH, a fatty liver disease that can lead to liver failure or cancer
Sahil Pandey / Reuters :
The US FDA clears hypertension notifications on Apple Watch, and Apple plans to roll out the feature to Series 11, 10, and 9, and Watch Ultra 3 and 2 next week
Chance Miller / 9to5Mac :
The US FDA clears hypertension notifications on Apple Watch, and Apple plans to roll out the feature to Series 11, 10, and 9, and Watch Ultra 3 and 2 next week
When Apple announced the new Apple Watch Series 11 and Apple Watch Ultra 3 this week, it unveiled its latest health feature: hypertension notifications.
The US FDA debuts an agencywide generative AI tool to help scientific reviewers and others streamline work and, soon, to find high-priority inspection targets
from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people. Elsa in Action ➤ [...
The US FDA plans to deploy AI tools to all centers by June 30, 2025 to speed up scientific reviews, after completing a pilot and naming its first AI chief
FDA Artificial Intelligence AI and Machine Learning Biotech — The FDA has appointed its first chief artificial intelligence officer …
The US FDA cleared Neuralink rival Precision Neuroscience in late March 2025 to offer a less invasive brain implant; the device contains 1,024 metal electrodes
Ike Swetlitz / Bloomberg :
The US FDA approves Apple Watch's AFib history feature for clinical studies, the first digital health tech qualified under the FDA's MDDT program
The FDA today announced that it has qualified the Apple Watch AFib ( Atrial Fibrillation) history feature as an MDDT (Medical Device Development Tools).
The US FDA warns the agency has not “authorized, cleared, or approved any smartwatch or smart ring” that claims to measure blood glucose levels non-invasively
As Apple Reportedly Tests Blood Sugar Tech X: @fdadeviceinfo : We issued a safety communication to warn that smartwatches and smart rings claiming to measure blood glucose levels without piercing the ...