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
Cysview’s New Prefilled Syringe Packaging Gets FDA Approval August 12, 2016 The device is now a prefilled syringe in a kit without needles. Read More
Spectranetics Earns CE Mark for AngioSculptX Drug-coated Catheter August 11, 2016 The device is designed to treat coronary artery stenosis. Read More
FlowAid Medical Earns CE Mark Approval for Sequential Compression Device August 10, 2016 This device causes an increase in venous blood flow from limbs. Read More
FDA: Request Small Business Status Before Sending FY 2017 Applications August 9, 2016 The establishment registration fee remains the same. Read More
FDA Approves Alcon’s Eye Stent August 8, 2016 The stent creates a drainage pathway to control intraocular pressure. Read More
Itamar’s Sleep Apnea Device Gains Indication August 4, 2016 Approved for use in patients as young as 12. Read More