Regentis Biomaterials Gets Expanded CE Mark for GelrinC August 30, 2017 The implant naturally degrades within 6 to 12 months as it’s replaced by cartilage. Read More
FDA Approves Abbott’s HeartMate 3 Implantable Pump August 30, 2017 The device won CE Mark approval in the European Union in October 2015. Read More
Singapore Launches Device Priority Reviews, Pre-Market Consultations August 29, 2017 Class A devices and those incorporating medicinal products are not eligible for the priority review scheme. Read More
DHS Flags Hacking Risk in Philips’ Radiation Monitoring App August 29, 2017 The software is used in the U.S., Australia, Japan and Europe for simplifying the analysis of collected radiation exposure doses. Read More
C.R. Bard Lands Additional Indication for Drug-Coated Balloon Catheter August 29, 2017 The approval was based on an investigational device exemption clinical trial that showed sustained clinical benefit and safety. Read More
FDA Approves Tandem’s Insulin Pump August 29, 2017 The software featured on the pump will also be available to current t:slim X2 Pump users. Read More
Bariatric Equipment Manufacturer Mishandled Complaints, FDA Says August 28, 2017 The company also failed to establish assembly procedures for several of its products. Read More
Turbo Wheelchair Cited For Record-Keeping, Procedures August 28, 2017 The company’s device history records were inadequate. Read More
FDA Clears Stryker’s Pedicle Screws August 28, 2017 The Serrato screws can be customized to fit the patient’s needs. Read More
Medtronic Gets CE Mark for Left Heart Lead August 28, 2017 The device is currently undergoing a clinical trial in the U.S. Read More
Integrity Systems Takes FDA Hit on Records, Software Validation August 25, 2017 The facility failed to validate the software it used for management of inventory and documentation of quality system records. Read More
Bariatric Equipment Manufacturer Mishandling Complaints, FDA Says August 25, 2017 The company also failed to establish procedures for the assembly of several of its products, the FDA said. Read More