September 16, 2021 By Jim Hammerand Leave a Comment CMS aborts launch of MCIT payment program for breakthrough devices
September 14, 2021 By Sean Whooley Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic
September 8, 2021 By Jim Hammerand Medtronic releases Navablate study results for bronchoscopic microwave ablation
August 12, 2021 By Sean Whooley ProPublica report raises questions about FDA’s handling of Medtronic’s HVAD
July 12, 2021 By MDO Staff Software as a medical device: Here’s how the regulatory landscape is changing
July 1, 2021 By Sean Whooley FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access
