OptiScan Biomedical's OptiScanner 5000 Receives 510(k) Clearance October 19, 2017 The device previously won CE Mark certification for use in the EU. Read More
NuVasive Wins Expanded 510(k) Clearance for TLX Interbody System October 18, 2017 The system is inserted through a conventional TLIF approach. Read More
Instrumentation Laboratory Receives FDA Clearance for HemosIL Assay October 18, 2017 The device provides enhanced detection of antibodies. Read More
Stryker Receives FDA Clearance for Cementless Knee Implant October 18, 2017 The device’s tibial baseplate and metal-backed patella components are enabled by Stryker's AMagine additive manufacturing technology. Read More
Philips Agrees to Suspend Defibrillator Production October 18, 2017 The GMP nonconformities identified at the Andover, Massachusetts and Bothell, Washington sites included inadequate CAPA procedures. Read More
FDA Proposes Framework for Quality Manufacturing Pilot Program October 17, 2017 The voluntary program is one of several initiatives the FDA has recently launched as it reevaluates how it allocates resources. Read More
TransEnterix Scores FDA Approval for Robotically-Assisted Surgical Device October 17, 2017 The system provides feedback for assessing the stiffness of tissue. Read More
FDA Expands Use for NuVasive’s Magnetic Limb Device October 17, 2017 The implantable platform uses an external remote controller for non-invasive, customizable treatments on long bones. Read More
Neuronetics’ MDD Therapy System Snags Shonnin Approval October 17, 2017 The system is approved for commercial distribution in the U.S. and it is CE marked. Read More
Philips Receives 510(k) Clearance for Ultrasound Device October 16, 2017 The transducer can assess diseases and disorders of small organs and musculoskeletal injuries. Read More
House Bill Targets Healthcare Cybersecurity October 16, 2017 The proposed group would also be charged with identifying the high-priority problems. Read More
FDA Commits to Patient Engagement at Inaugural Advisory Committee Meeting October 16, 2017 The latest reauthorization of MDUFA provided money for the first time to build out the center’s patient engagement effort. Read More