Amedica Earns FDA Clearance for Expanded Sizes of Valeo II Lateral Lumbar Device August 24, 2016 The expanded sizes are intended to accommodate a broader range of patient anatomies. Read More
Edwards Transcatheter Heart Valves Approved in Intermediate-Risk Patients August 22, 2016 The FDA lowers the risk level required for use of the heart valves. Read More
FDA Grants Approval for Expanded Indication for 2 Transcatheter Heart Valves August 19, 2016 FDA is requiring manufacturers to monitor patients in clinical studies for 10 years. Read More
Alere Receives FDA Clearance for Alere I RSV Rapid Molecular Test August 19, 2016 The device delivers results in 13 minutes or less. Read More
FDA Simplifies Tips for Electrosurgical Device, Vessel Sealer Submissions August 19, 2016 FDA is advising sponsors to rely on an original 510(k) as a reference. Read More
Chinese FDA Awards MammaTyper Innovative Product Status for Expedited Approval August 19, 2016 Only ten in vitro diagnostics devices have been granted access to the special approval process. Read More
Masimo Receives CE Mark for RAS-45 Sensor August 18, 2016 RAS-45 is an adhesive sensor that monitors the respiration rate of patients. Read More
Levita’s Magnetic Surgical System Magnetics Receives FDA Clearance August 17, 2016 There are more than 1,000,000 gallbladder removal surgeries annually in the U.S. alone. Read More
BioSense Webster’s Thermocool SmartTouch Catheter Gets FDA Approval August 16, 2016 The catheter is designed to be integrated into the company’s Carto 3 system. Read More
NovaBone Products Obtains GMP Medical Device Certificate August 16, 2016 This certificate extends the distribution of device products for NovaBone. Read More
Conventus Receives Clearance for Conventus Cage DU and PU Systems August 15, 2016 The device uses nitinol to provide shape memory. Read More
Edwards Lifescience’s Rapid Deployment Valve Receives FDA Approval August 15, 2016 The device was approved based on trial data of 839 patients in the U.S. Read More