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
Medtronic Receives FDA Approval of Spinal Cord Stimulator September 20, 2017 The device is a non-opioid therapy for treating chronic pain. 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
Edap Seeks New Marketing Clearance for Ultrasound Device September 15, 2017 The new application includes a new set of clinical data. Read More
Douglas Medical Products Wins FDA 510(k) Clearance for IV Administration Set September 15, 2017 The company said it will launch the product immediately. Read More
Pulse Biosciences Pulls FDA 510(k) Application September 14, 2017 The company plans to re-file with additional information. Read More
Leica Wins FDA Clearance for Novel Microscopy Filter September 14, 2017 The device combines two illumination methods. Read More