October 22, 2020 By Chris Newmarker

Are Stephen Hahn’s days numbered at FDA?

October 22, 2020 By Sean Whooley

Applied VR gains FDA breakthrough device nod

October 16, 2020 By Nancy Crotti

Saraca Solutions seeks to slash clinical evaluation report times

October 15, 2020 By Danielle Kirsh

Chinese regulators delay medical device UDI implementation

October 14, 2020 By Nancy Crotti

Aferetica, CytoSorbents gain EU nod for organ perfusion system

October 14, 2020 By Danielle Kirsh

MDR mutual recognition agreement unresolved after Swiss referendum

October 13, 2020 By Nancy Crotti

CartiHeal wins FDA breakthrough designation for Agili-C implant

October 9, 2020 By Sean Whooley

Olympus gains 510(k) clearance for colonoscopes

October 6, 2020 By Sean Whooley

CDRH director Shuren says flexibility remains key as COVID-19 strains regulatory system

October 6, 2020 By Nancy Crotti

BD’s automated flow cytometry system wins FDA clearance

October 1, 2020 By Sean Whooley

SurGenTec wins FDA nod for 3D GraftRasp system

September 30, 2020 By Nancy Crotti

Surgical Innovation Associates gains CE Mark for absorbable mesh

September 29, 2020 By Nancy Crotti

Federal rule on ethylene oxide now delayed until 2021

September 29, 2020 By Nancy Crotti

Pulse Biosciences gains MDSAP certification

September 23, 2020 By Nancy Crotti

FDA to clarify role of off-label uses in medical device approvals

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