FDA Spells Out Which Microneedlers Are Medical Devices September 21, 2017 Not covered by the guidance are acupuncture needles, hypodermic needles, tattoo needles or laser and ultrasound needle probes. Read More
Masimo Wins FDA Nod for Rad-97 Pulse Oximeter September 21, 2017 The device supports wireless connections to compatible thermometers, glucometers, and weight scales. Read More
Mazor Robotics Snags CE Mark for Surgical Platform September 21, 2017 The device will be marketed in Europe by the company’s commercial partner Medtronic. Read More
Philips Launches CardioMD IV for Cardiac Imaging September 20, 2017 The device provides enterprise-wide access to the latest cardiac SPECT quantification, review and reporting applications. Read More
SurModics Wins 510k Clearance and CE Mark for Balloon Dilation Catheter September 20, 2017 The company plans to launch the device in the coming months. Read More
FDA Officials Show Support for Risk-Based CAPA Strategy September 20, 2017 Officials welcomed the risk-based framework as a good baseline, but cautioned that each CAPA should be independently assessed. Read More
Medtronic Receives FDA Approval of Spinal Cord Stimulator September 20, 2017 The device is a non-opioid therapy for treating chronic pain. Read More
Johnson & Johnson Hit With $57.1 Million Judgment in Pelvic Mesh Case September 19, 2017 Doctors initially implanted the device mesh in May 2007. Read More
FDA Extends Datascope Field Correction to Class 1 Recall September 19, 2017 The agency cited a false blood detection alarm and ingress of fluid into the devices. Read More
App for Substance Abuse Treatment Wins FDA Marketing Clearance September 19, 2017 The app delivers cognitive behavior therapy that teaches skills for increasing abstinence. Read More
FDA Approves GlaxoSmithKilne’s Triple Trelega Ellipta Inhaler September 19, 2017 A European Medicines Agency panel also recommended approval of the device. Read More
FDA Deflates Sales, Imports of Dutch Endorectal Balloons September 18, 2017 QLRAD promoted the device for use with radiation therapy on its web site and in brochures distributed at medical conferences, the FDA said. Read More