July 22, 2021 By Sean Whooley

FDA seeks expanded authority to boost medical device supply chain

July 12, 2021 By MDO Staff

Software as a medical device: Here’s how the regulatory landscape is changing

July 9, 2021 By Sean Whooley

FDA warns of biocompatibility concerns with NuVasive’s Precise devices

July 1, 2021 By Sean Whooley

FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access

June 22, 2021 By Danielle Kirsh

Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant

June 17, 2021 By Nancy Crotti

FDA issues docs on medtech remanufacturing, servicing

June 15, 2021 By Sean Whooley

Former FDA commissioner Hahn to join VC behind Moderna

June 2, 2021 By Nancy Crotti

Italian sterilization plants falsified records for years, FDA says

June 2, 2021 By Nancy Crotti

FDA seeks more money, authority in budget request

June 2, 2021 By Nancy Crotti

Edwards’ low-BP prediction software gains FDA clearance

May 28, 2021 By Nancy Crotti

FDA shifts gears as mask shortages ease

May 26, 2021 By Nancy Crotti

FDA issues draft guidance on medical device postmarket issues

May 24, 2021 By Nancy Crotti

BD applicators cited in medical kit recall

May 21, 2021 By Sean Whooley

How Fractyl Labs is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections

May 20, 2021 By Sean Whooley

FDA leapfrogs guidance on brain-computer interface devices

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