Viveve Wins Approval for Viveve System in Mexico October 19, 2017 The company plans to submit an investigational device exemption to the FDA to conduct a pivotal trial. Read More
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
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
FDA Clears Siemens Healthineers’ Terra 7T MRI Scanner October 13, 2017 The device produces cross-sectional images of the head and knee. Read More
Alcon Receives CE Mark for Preloaded Intraocular Lens Delivery System With Clareon October 13, 2017 Clareon maintains the benefits of the AcrySof platform with a new optic BioMaterial that offers cataract patients optic clarity. Read More
Abacus Diagnostica Receives CE Mark for Norovirus GI and GII October 13, 2017 Launch Diagnostics is partnering with Abacus Diagnostica to supply the kits. Read More