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The agency seeks to draw on outside expertise to "ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation," says the director of its Center for Devices and Radiological Health.
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…
The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.