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
FDA Sacks Eye-Sync as Concussion Assessment Device September 18, 2017 The device resembles a set of virtual-reality goggles connected wirelessly to a suitcase-sized, portable input processing unit. Read More
FDA Approves Two Ortho Hepatitis B Assays September 18, 2017 The assays are used to diagnose individuals with acute or chronic hepatitis B or in recovery from hepatitis B infection. Read More
FDA Clears Agilent’s GenetiSure Dx Postnatal Assay September 18, 2017 The device is intended for use on the Agilent SureScan Dx microarray scanner system. Read More