June 9, 2025 By MDO Contributors Network Leave a Comment

Device developers must take action as experts leave FDA

June 3, 2025 By Danielle Kirsh

FDA rolls out ‘Elsa,’ a generative AI tool to boost efficiency across the agency

May 12, 2025 By Carrie Pallardy

The FDA is turning to generative AI to boost efficiency

May 7, 2025 By Sean Whooley

FDA plans more unannounced inspections of foreign facilities

April 3, 2025 By Jim Hammerand

Former CDRH Director Jeff Shuren on what FDA cuts might mean for device developers

March 6, 2025 By Jim Hammerand

What’s next for Capstan Medical after their first-in-human robot-assisted transcatheter heart valve replacement

January 21, 2025 By Danielle Kirsh

FDA’s Tarver pushes for mandatory medical device shortage reporting

January 15, 2025 By Danielle Kirsh

FDA finalizes guidance for device shortage notifications

January 14, 2025 By Danielle Kirsh

FDA releases draft guidance for pulse oximeter accuracy

January 10, 2025 By Sean Whooley

FDA issues new guidance on AI-enabled device software functions

December 23, 2024 By Danielle Kirsh

Vision check with FDA CDRH Director Dr. Michelle Tarver

November 27, 2024 By Jim Hammerand

FDA warns of device shortage after Class I recall for silicone debris injuries

November 22, 2024 By Jim Hammerand

Faster breakthrough device coverage might be on the way

November 21, 2024 By Jim Hammerand

Can Maryland make Baltimore the next medtech hub?

November 20, 2024 By Danielle Kirsh

FDA to address regulatory challenges for generative AI in medtech

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