ICAD Gains FDA Clearance for PowerLook Tomo Detection April 13, 2017 The software will be available in the market later in 2017. Read More
Health Canada Approves Sight Sciences Viscosurgical System April 13, 2017 This single-use device provides a 360-degree canal procedure. Read More
Entellus Medical Gains FDA Clearance for Eustachian Tube Indication April 13, 2017 The clearance was based on clinical trial results that showed no complications or side effects. Read More
United Orthopedic Receives FDA Clearance for Its Polyethylene Knee Insert April 12, 2017 The device is blended with 0.1 percent vitamin E. Read More
Stimwave Wins Australian Regulatory Approval for Its Freedom Spinal Cord Stimulation System April 12, 2017 The device is a wireless neuromodulator. Read More
FDA Awards Marketing Clearance to Mazor Robotics’ Spinal Deformity Correction Planning Software April 12, 2017 Mazor X is an extension to the company’s proprietary pre-operative analytics software. Read More
Ventec Life Systems Gains FDA Clearance of VOCSN April 12, 2017 Patients can get all five therapies or just the mix of therapies needed. Read More
FDA Collaborates with Emulate to Use Organs-on-Chips Technology as a Toxicology Testing Platform April 11, 2017 The intention of this study is to predict the effects on human biology of chemical and microbiological hazards. Read More
Eyevensys Wins ANSM Approval for Clinical Development of Its EyeCET Platform April 11, 2017 The device is intended to treat ophthalmic diseases. Read More
REVA Receives CE Mark for Its Bioresorbable Coronary Scaffold April 11, 2017 This device is an alternative to metal stents to treat coronary artery disease. Read More
FDA Grants Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2 April 11, 2017 The device received CE marking in August 2016. Read More
Industry Reps Cite Tight Timeline for MDUFA IV April 10, 2017 AdvaMed’s CEO praised “ground-breaking” process improvements in the MDUFA III agreement. Read More