IMDRF Clarifies When Competent Authorities Can Share Confidential Information November 2, 2017 New guidance covers sharing information when there is a serious health threat associated with a medical device. Read More
FDA Clears Ultrasound and Electric Field Simulation Device November 2, 2017 The device includes software that provides an integrated patient and wound management system. Read More
Abbott Secures FDA Clearance for Diagnostic Systems November 2, 2017 The separate systems for clinical chemistry testing and immunoassay testing can be used individually or as a unit. Read More
Sanofi Files Patent Infringement Suit Against Mylan Over Lantus Generic November 1, 2017 Sanofi requested a discovery order for the NDA and an injunction to block Mylan using 18 patents. Read More
PTAB Grants First Review Extension November 1, 2017 A recent ruling set a precedent that affects the burden of proof the patent board applies. Read More
IRadimed Receives FDA 510(k) Clearance of MRI Compatible Patient Vital Signs Monitor November 1, 2017 The device has a wireless tablet remote control that allows for the effective communication of vital signs to clinicians. Read More
Abbott Receives CE Mark for XIENCE Sierra Stent November 1, 2017 Abbott submitted an application to the FDA for XIENCE Sierra approval. Read More
Gottlieb: Puerto Rico Device Firms Still Operating Below Capacity October 31, 2017 Puerto Rico has more than 50 medical device facilities manufacturing upwards of 1,000 devices. Read More
FDA Issues Guidance for New Breakthrough Devices Program October 31, 2017 The draft guidance describes the process for seeking a breakthrough device designation. Read More
Butterfly Network Receives 510(K) Clearance for Chip-Based Imaging System October 31, 2017 The company develops artificial intelligence applications. Read More
Alcyone Wins CE Mark for Alivio Ventricular Catheter and Flusher System October 31, 2017 The system is designed to unblock ventricular catheters. Read More
Nitiloop Wins FDA 510(k) Clearance for Microcatheters October 30, 2017 The company produces cardiovascular and peripheral microcatheters for complex lesions. Read More