The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices.

A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers ...

A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and insulin pumps is struggling with simple tasks, according to two ...

For people diagnosed with macular telangiectasia type 2 (MacTel)—a rare and slowly progressing retinal disease—there have ...

Sonu, an AI-enabled wearable device, is now approved for use in pediatric patients aged 12 years and older for the relief of moderate to severe nasal ...

On Jan. 6, 2024, FDA released ... to all AI-enabled devices and is applicable across a broad scope of marketing submissions, including premarket notification (510(k)) submission, De Novo ...

Cyberattackers are well aware of medical device software weaknesses. Are you? RunSafe Security CEO Joe Saunders offers ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...

Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 ...

Paradromics' Brain-Computer Interface has been tested briefly in a patient with epilepsy. Neuralink, Precision Neuroscience, and Synchron also have devices in the works. Other news looks at a ...

There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by ...