Global Kinetics Corp said today it won FDA 510(k) clearance for its next-gen wrist-worn personal kinetigraph system. The device is designed to record movement symptoms of Parkinson’s and provides medication reminders and aid in making assessments about response to medication, the Melbourne, Australia-based company said. “Our new second generation PKG represents the most recent milestone in […]
510(k)
FDA clears components for K2M’s Mesa spine implant
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for screw and connector components used as part of the company’s Mesa spinal system. The newly cleared components from the Leesburg, Va.-based company are designed to be used as part of a growing rod construct designed to accomodate growth in pediatric patients 10 years and younger. “We are […]
FDA approves Nuvasive’s Reline system for Magec spine implants
NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for the Reline posterior fixation system used with its Magec device for treating severe spinal deformities. The Reline system is designed with an integrated global alignment platform designed to treat patients through open or minimally invasive procedures. Magec is a magnetically controlled growing-rod system cleared […]
Varian wins FDA clearance for Nexus DR digital X-ray
Varian Medical (NYSE:VAR) said yesterday that it won 510(k) clearance from the FDA for its Nexus DR digital X-ray system. The Palo Alto-based company markets the device as a single common imaging platform intended for general radiographic procedures, but not for fluoroscopy, angiography, or mammography. The announcement comes a week after Varian acquired Polish distributor […]
FDA approves Kerecis Omega3 SecureMesh fish-skin surgical mesh
Kerecis said today that it won 510(k) clearance from the FDA for its Kerecis Omega3 SecureMesh regenerative surgical mesh for use in lung, bariatric, gastric, colorectal and other surgeries. The McLean, Va.-based company said the Kerecis Omega3 mesh is made from intact fish skin saturated in naturally occurring Omega3 polyunsaturated fatty acids. Kerecis said the material […]
Ethicon wins FDA nod for Enseal X1 tissue sealer
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won FDA 510(k) clearance for its Enseal X1 large jaw tissue sealer designed for vessel sealing and precise heat management. The Somerville, N.J.-based company said the newly cleared Enseal X1 is an advanced bipolar device designed for use in open procedures, such as colectomies and hysterectomies. “Ethicon remains committed […]
FDA clears icometrix’ MRI quantification software
Health tech software developer icometrix said today it won FDA 510(k) clearance for its icobrain image quantification software. The company’s icobrain software is designed to quantify key features of clinical magnetic resonance imaging brain scans to allow clinicians to monitor changes in their patient’s brains over time. “MRI biomarkers are becoming of vital importance in […]
Carestream wins FDA clearance for extremities CT scanner
Carestream Health said today it won FDA 510(k) clearance for its OnSight 3D extremity system. The Rochester, N.Y.-based company’s newly cleared device uses cone beam CT tech to capture weight-bearing and other types of extremity exams. The system is designed for use by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare […]
FDA clears Additive Orthopaedics’ 3D-printed osteotomy wedge
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed osteotomy wedge system. The newly cleared device from the Little Silver, N.J.-based company is designed to treat bone fractures or osteotomies in the foot and ankle. “The complex geometry and unique lattice structure, which is only possible through the […]
Braun lands FDA nod for Xevonta dialyzer
B. Braun Medical said today it won FDA 510(k) clearance for its xevonta dialyzer and that it is launching the next-generation filter in the U.S. Get the full story at our sister site, Medical Design & Outsourcing.
FDA clears Siemens’ Somatom Drive CT scanner
Siemens (NYSE:SI) said yesterday it won FDA 510(k) clearance for its Somatom Drive computed tomography dual-source scanner. The newly-cleared Somatom Drive system is designed to include Straton MX Sigma X-ray tubes and Sigma generations which the company said enables more targeted beam focusing and eliminations using high energy levels at low voltages. Low voltage levels could […]