FDA Clears BioFire’s FilmArray Torch for Use With 3 More Panels April 8, 2016 The system was previously cleared for use with the FilmArray respiratory panel. Read More
Abiomed’s Impella Therapy Snaps Up Premarket Approval April 8, 2016 The pumps are intended for short-term treatment of ongoing cardiogenic shock. Read More
NetBio’s DNAscan System Gains NDIS Approval from FBI April 7, 2016 The system can produce a DNA profile in less than 90 minutes. Read More
VolitionRx Earns 2 CE Marks for Colorectal Cancer Tests April 7, 2016 Last September, the company’s NuQ X001S assay received CE marking for the same indication. Read More
Sleep Profiler PSG2 Garners FDA Clearance April 6, 2016 The Sleep Profiler measures REM associated with obstructive sleep apnea. Read More
K2M Wins Expanded Indications for Spinal Systems April 6, 2016 The systems previously were cleared for use in the posterior thoracic spine, from T1-T3. Read More
Merck KGaA, Sysmex Inostics Nab CE Mark for Colorectal Cancer Test April 6, 2016 The assay consists of a 34-mutation panel. Read More
Visunex Medical’s PanoCam LT System Nabs CE Mark April 4, 2016 The system secured FDA clearance in November 2015. Read More
Ekso GT Robotic Exoskeleton Earns FDA Clearance April 4, 2016 Ekso GT is the first FDA-cleared exoskeleton for use in stroke patients. Read More
FDA Grants CardioFocus’ HeartLight Premarket Approval April 4, 2016 The system is indicated for treating drug refractory recurrent symptomatic paroxysmal AF in the U.S. Read More
Xtant Receives FDA Clearance for Spinal Laminoplasty System March 31, 2016 The device is intended to remove pressure from the spinal cord. Read More