August 17, 2021 By Danielle Kirsh

FDA clears Able Medical’s Mach screw clip system

August 17, 2021 By Danielle Kirsh

Globus Medical’s Excelsius3D imaging system wins FDA clearance

May 20, 2021 By Nancy Crotti

Feds want more input on materials with ‘high-profile safety concerns’

April 29, 2021 By Nancy Crotti

FDA to drop 510(k) submission pilot

March 24, 2021 By Nancy Crotti

GE Healthcare 2D/3D imaging system wins FDA nod

March 3, 2021 By Nancy Crotti

Origami Surgical gains FDA clearance for robotic suturing devices

December 18, 2020 By Nancy Crotti

SeaSpine gains FDA clearance for new uses of surface technology

March 11, 2020 By Nancy Crotti

FDA issues final guidance on third party reviews

February 27, 2020 By Nancy Crotti

FDA launches pilot to streamline 510(k) process

August 15, 2019 By Ashley Holub

Boeing’s 737 Max crisis: Why the medical device industry should care

December 17, 2018 By Chris Newmarker

Medical device industry regulation is changing: What you need to know

December 5, 2017 By Heather Thompson

How BioSig is using plug and play as a medtech startup strategy

April 18, 2017 By Chris Newmarker

What does FDA really mean when something is 510(k) exempt?

December 20, 2016 By Chris Newmarker

Changing your medical device: 6 things you need to know