Mimedx says market overreacted to FDA's recent HCT/P guidance Nov. 16, 2015 By Richie Crider No Comments
Panel Looking into Complaints: Bayer eschews calls to recall Essure device despite safety concerns Oct. 1, 2015 By Richie Crider No Comments
FDA issues stern warnings to Sironis, others over unapproved market actions Sep. 30, 2015 By Richie Crider No Comments
Warning Letter Review: FDA dings Cardiac Designs for complaint handling, CAPA failures Sep. 8, 2015 By Richie Crider No Comments
Cost of doing business in China likely to increase under new GMPs Aug. 17, 2015 By Richie Crider No Comments
Overwhelmed by robot onslaught? As pace of RASD development quickens, FDA turns to industry Aug. 10, 2015 By Richie Crider No Comments
Inside the beltway: Medtronic initiates recalls of CoreValve system component amid safety concerns Aug. 10, 2015 By Richie Crider No Comments
Inside the Beltway: FDA issues safety advisory on LVADs warning of serious adverse events Aug. 7, 2015 By Richie Crider No Comments
Cook's Beacon gets Recall: Cook Medical initiates global recall of nearly 100K Beacon catheters Aug. 6, 2015 By Richie Crider No Comments
Inside the Beltway: FDA targets management at AG Industries; HeartWare provides updates HVAD recall June 29, 2015 By Richie Crider No Comments