FDA Clears NanoCoated Coronary Stent System March 23, 2017 The stent is designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease. Read More
FDA Grants Marketing Clearance to Icare HOME Tonometer March 23, 2017 The device is intended to assist clinicians and patients to monitor glaucoma 24/7. Read More
Alcon Wins FDA Clearance for AcrySof IQ Lens March 23, 2017 The central portion of the lens is dedicated to distance vision. Read More
FDA Clears Medtronic’s Transcatheter Valve with Advanced Sealing March 22, 2017 The 23mm, 26mm and 29mm sizes of the device are available for use in the U.S. Read More
FDA Grants Clearance to BioStable Science & Engineering’s Aortic Annuloplasty Device March 22, 2017 This device is designed for aortic valve repair. Read More
European Union Grants CE Mark to Nucleix's Bladder EpiCheck March 22, 2017 The device includes a panel of 15 proprietary biomarkers. Read More
CDRH Debuts the 2017 Experiential Learning Program March 22, 2017 The formal training visits are not compliance or enforcement actions. Read More
IMDRF Round Up: Forum Plans Guidance on UDIs, SaMD March 21, 2017 IMDRF members discussed the planned guidance at the forum’s meeting. Read More
MHRA Issues Guidance on Leadless Pacemaker Clinical Studies March 21, 2017 MHRA says manufacturers should work to minimize bias and make inherent design limitations explicit. Read More
FDA Publishes List of Class II 510(k) Exemptions March 21, 2017 In some cases, the agency may limit exemptions to specific devices or tests within a given type. Read More
Japan’s MHLW Clears Novocure Second Generation Optune March 20, 2017 The device is lighter and smaller than the first generation. Read More
FDA Awards Marketing Clearance to Trovita Health Science’s Nutrition Delivery Device for Tube Feeding March 20, 2017 The device simplifies the tube feeding process. Read More