Stay updated with breaking news from Devices Program. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If...
On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff."
We remember the late Jimmy Buffett who sang in his 1977 classic, “Changes in latitudes, changes in attitudes; Nothing remains quite the same.” Demonstrating a change in attitude, in...
Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) clearance from the U.S. Food and Drug Adm…
First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program