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 ...

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 ...

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

The new test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, detects amyloid plaques through blood testing, a type of protein indicative of Alzheimer's, the Alzheimer's Association ...

Vivani Medical is developing GLP-1 subdermal implants that aim to provide a consistent therapeutic dose for six months, and ...

For the first time, the FDA has just approved a device that lets people screen for cervical cancer from home. Known as the ...

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

U.S. officials have approved the first cervical cancer test that allows women to collect their own sample at home.

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 ...