Japanese MHLW Aligns ISO 13485:2016 with Its Own QMS Requirements August 17, 2016 Japan is to merge new quality system standards with its own requirements. 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
TGA Maps Transition to ISO Quality Management Standard August 17, 2016 The agency clarified that the 2003 and 2016 standards will co-exist during the three-year transition period. Read More
FDA Pursues Feedback on Classification of Antimicrobial Wound Care Products August 17, 2016 These products have not yet been classified. 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
DT MedTech Gets CE Marking and Begins Selling of Hintermann Series H3 Devices August 16, 2016 These devices are used for foot and ankle replacements. Read More
Antibe Therapeutics Launches Neomem FlexPlus August 16, 2016 The device is a single-layer collagen membrane made from porcine peritoneum. Read More
NovaBone Products Obtains GMP Medical Device Certificate August 16, 2016 This certificate extends the distribution of device products for NovaBone. Read More
More Postmarket Data Collection Could Allow Transferal from Class III to Class II August 16, 2016 The reclassification effort is connected with the CDRH’s strategic priorities to reduce premarket data. Read More
Arch Presents Data for AC5 Topical Hemostatic Device from First Clinical Study August 15, 2016 The device is designed to control bleeding and fluid loss. Read More
Teleflex Presents New Second-Generation Percuvance System August 15, 2016 The second generation device has additional interchangeable 5 mm tool tips. 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