Actamax Requests IDE From FDA for Its Sprayable Adhesion Barrier Device Study February 22, 2017 Previous study indicated the device improved long-term outcomes. Read More
BD Claims Influenza Detection Test Meets FDA's New Performance Requirements February 22, 2017 The FDA has reclassified rapid flu tests from Class I to Class II. Read More
FDA Cites Neo Vision for Design Controls February 22, 2017 The company failed to implement design controls and establish a design history file. Read More
New Bill Would Harmonize FDA Device Inspections February 22, 2017 The bill would adopt a risk-based approach to inspections. Read More
DiaCarta Nabs CE-IVD for its Non-Invasive Colorectal Cancer Test February 21, 2017 The device is designed to detect CRC mutations in DNA. Read More
FDA Awards Voxello Marketing Clearance For Speech Generation Device February 21, 2017 The device detects voluntary gestures as communication for those unable to speak. Read More
Philips Gains FDA Marketing Clearance For Its Next-Generation Of Intellivue Guardian Solution February 21, 2017 The device constantly measures heart rate, respiratory rate, posture and detects falls. Read More
GAO: FDA Overlooked Cancer Risks in Medical Devices February 21, 2017 The agency decided the danger was not sufficient to warn women or doctors. Read More
Medtronic Granted Japanese Regulatory Approval for Micra Transcatheter Pacing System February 17, 2017 The Micra TPS is less than one-tenth the size of traditional pacemakers. Read More
Chaffetz Vows Subpoena If Mylan Foot-Dragging Continues February 17, 2017 Chaffetz demanded the full, unredacted requested documentation in-camera by the end of February. Read More
South Africa Releases Draft Regs For Drug-to-Device Transfers February 17, 2017 Transfer applications must be made by the manufacturer’s authorized representative. Read More
UK’s MHRA Proposes New Medical Device Fees February 17, 2017 Most of the new fees will come from notified bodies. Read More