FDA, Industry Make Strides on Case for Quality Guidance July 5, 2016 The agency expects to release draft guidance on quality metrics for devices within the next few months. Read More
Proposed Rule Calls for More Data on Imported Devices July 5, 2016 The rule calls for additional product identification information. Read More
FDA, Industry Inch Closer Toward MDUFA Agreements July 5, 2016 A MDUFA counter-proposal suggests a slowly closing gap between negotiations. Read More
Ethicon Lands FDA Clearance for Harmonic HD 1000i July 5, 2016 The device is intended for use in difficult open and laparoscopic procedures. Read More
Dentsply Sirona Acquires MIS Implants July 1, 2016 MIS Implants is a dental implant systems manufacturer. Read More
Conavi Medical Appoints Murray Maynard as New CEO July 1, 2016 Maynard assumed his new duties yesterday. Read More
Biotronik Earns CE Mark Approval July 1, 2016 Edora pacemakers should have over 14 years of longevity. Read More
Medtronic Picks Up HeartWare July 1, 2016 Under the deal, Medtronic will gain all outstanding shares for $58 per share. Read More
BioMérieux Wins FDA Clearance July 1, 2016 The clearance broadens the use of the company’s Vidas BRAHMS PCT assay. Read More
AtriCure Earns CE Mark for AtriClip PRO2 June 30, 2016 The device was launched in April 2016 in the U.S. Read More
Accuray Wins FDA Clearance for Radixact Platform June 30, 2016 The company expects to launch the Radixact system in 2017. Read More
MHRA Makes Changes to Quicksite, Quickflex Alert June 30, 2016 The agency updated a 2012 medical device alert for Quicksite and Quickflex devices. Read More