CareStream Health said yesterday it won FDA 510(k) clearance for its Vue Motion universal viewer system designed for the diagnostic viewing of electrocardiogram waveforms. The system is designed for clinicians, physicians and cardiologists to view ECG exams for patients with ST segment elevation myocardial infarction and other heart conditions and illnesses, the Rochester, N.Y.-based company […]
510(k)
Vertera Spine wins FDA nod for porous PEEK fusion device
Vertera Spine said yesterday it won FDA 510(k) clearance for its porous PEEK Cohere cervical interbody fusion device. The Cohere device is composed entirely of Vertera Spine’s novel PEEK Scoria porous biomaterial which the company said is more durable than metal coatings and 2 times stronger under shear loading than trabecular bone. “The FDA clearance […]
Hitachi wins FDA 510(k) for Supria CT system
Hitachi (NYSE:HIT) said yesterday it won FDA 510(k) clearance for its Supria 16-slice CT system imaging platform. The new device features a compact design and a Smart-Dose compliant dose saving system that can reduce the amount of radiation for the patient undergoing imaging, the company said. “Supria demonstrates Hitachi’s continuing commitment to provide superior product value […]
Varian Medical wins FDA 510(k), CE Mark for VitalBeam
Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its VitalBeam radiotherapy system. The VitalBeam system is a modular, high-throughput radiotherapy system which incorporates technology from the company’s TrueBeam radiotherapy system, the Palo Alto, Calif.-based company said. “The VitalBeam system will enable us to complete image-guided […]
Corindus wins FDA nod for radial access stenting with CorPath
Corindus Vascular Robotics (OTC:CVRS) said today it won FDA 510(k) clearance for its robotic-assisted CorPath System for use during percutaneous coronary interventions stenting procedures performed via radial access. The approval was based on results from a 30-patient clinical trial of the device that demonstrated a 100% device and clinical success rate, the Waltham, Mass.-based company said. “Radial […]
EarLens wins FDA 510(k) for novel hearing aid
EarLens said Tuesday it won FDA 510(k) clearance for its laser diode-equipped direct vibration-based contact hearing device for use in adults with mild to severe sensorineural hearing impairment. The device is designed to directly contact the patient’s eardrum and use it as a speaker and act as an amplifier for a wide range of frequencies, […]
Implanet wins expanded FDA 510(k) for Jazz band device
French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems. The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures. The […]
Advanced Cath. pulls down 2nd 510(k) for Occlusion Perfusion catheter
Advanced Catheter Therapies said today it won a 2nd FDA 510(k) for its Occlusion Perfusion catheter, covering a new range of sizes for the device. The OPC is a multi-lumen balloon catheter designed to occlude vessels for the local delivery of therapeutic agents, the Chattanooga, Tenn.-based company said. “ACT is very excited about this second […]
Ceterix Orthopaedics wins FDA 510(k) for NovoStitch Plus
Ceterix Orthopaedics said today it won FDA 510(k) clearance for its NovoStitch Plus meniscal repair system designed for patients with meniscal tearing. The device is a next-generation version of the company’s NovoStitch, designed to treat a variety of different meniscal tears, the Menlo Park, Calif.-based company said. “The main difference is the NovoStitch Plus has […]
Precision Spine wins 510(k) for pedicle screw
Precision Spine said today it won FDA 510(k) clearance for its reform modular and hydroxyapatite coated pedicle screw systems. The modular screw system is designed with a cobalt chrome tulip and proximal tapered triple lead thread designed to enhance pull-out strength and increase visibility, the Parsippany, N.J.-based company said “The Reform system is one of the […]
FDA clears MagVenture’s MagVita TMS
Non-invasive magnetic stimulation developer MagVenture said last month it won FDA 510(k) clearance for its MagVita transcranial magnetic stimulation therapy system. The device, which uses magnetic fields and electric currents to excite and depolarize neurons in the brain and nervous system, is indicated for treating major depressive disorder in patients non-receptive to antidepressant medication, the […]