FDA Grants Marketing Clearance for Heidelberg Engineering’s Spectralis OCT Glaucoma Module Premium Edition September 22, 2016 The new technology allows the module to create an anatomic map unique to each patient’s eye. Read More
Medtronic Drug-Coated Balloon Approved for In-Stent Restenosis September 21, 2016 The expanded indication for the device marks the first approval in the U.S. for a drug-coated balloon. Read More
FDA Grants 510(k) Clearance to GI View’s Aer-O-Scope Disposable Colonoscope System with Therapeutic Access September 20, 2016 More than 690,000 people worldwide die from colorectal cancer annually. Read More
Claret Medical Submits Marketing Application to FDA for Combination Device September 20, 2016 A device is designed to protect the brain by capturing and removing debris dislodged during TAVR. Read More
ViewRay Obtains CE Mark for its MRIdian Linac System September 19, 2016 The company has also submitted its 510(k) application for the device in the U.S. Read More
Boston Scientific is Granted CE Mark For LOTUS Edge Valve System September 19, 2016 Its additional feature includes the Adaptive Sea technology, which minimizes leakage. Read More
Zeiss Receives FDA Approval for Laser Eye Surgery Device September 16, 2016 SMILE is a femtosecond laser-based vision correction procedure. Read More
Advanced Accelerator Applications Gets Positive EMA Opinion on Application for SomaKit TOC September 16, 2016 The European Commission’s official marketing authorization is expected soon. Read More
FDA Clears Shockwave Medical’s Lithoplasty System September 16, 2016 The device is designed to selectively target hardened calcium in patients with cardiovascular disease. Read More
FDA Grants Approval to Obalon Balloon System September 13, 2016 There were 387 patients in the U.S. across 15 clinical trial sites in the study. Read More
FDA Gives ‘Go Ahead’ to Omega3-Rich Fish Skin for Surgical Applications September 13, 2016 Kerecis’s Omega3-rich fish skin has received clearance from the FDA for marketing as a surgical reinforcement in the U.S. Read More
EBR Systems Obtains FDA Approval to Begin Study of Wireless Cardiac Pacing System for Heart Failure September 13, 2016 The company’s device is designed as an endocardial pacing system. Read More