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The US FDA

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Coverage Timeline

2025-12-09
Reuters 1 related

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 :

2025-10-20
The Verge 7 related

Oura launches a redesigned app with a new feature showing a weekly overview of stress management and says it's working with the US FDA on a blood pressure study

The company is launching a study that uses ring data to detect ‘early signs of hypertension.’

2025-09-13
9to5Mac 27 related

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 :

2025-09-12
9to5Mac 19 related

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.

2025-06-03
Axios 9 related

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 ➤ [...

2025-05-10
Fierce Biotech 12 related

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 …

2025-05-08
Wired 6 related

Sources: OpenAI employees met with the US FDA and two DOGE associates multiple times in recent weeks to discuss cderGPT, a project likely around drug evaluation

High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT.

2025-04-17
Bloomberg 2 related

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 :

2025-04-07
Washington Post

AI is aiding radiologists with tools like tumor-detection algorithms; 75%+ of AI software cleared by the US FDA for medical use is designed to support radiology

Jamie Friedlander Serrano / Washington Post : Bluesky: @lauridonahue . X: @christinayiotis Bluesky: Lauri Donahue / @lauridonahue : This is an example of GOOD (non-generative) AI.  It's about recogni...

2024-05-03
MyHealthyApple 10 related

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).

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