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 […]
510(k)
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 […]
Fortimedix wins FDA nod for FMX314 single-port surgery platform
Fortimedix Surgical said today it won FDA 510(k) clearance for its FMX314 single-port system for minimally invasive abdominal laparoscopic surgery. Netherlands-based Fortimedix touted the newly cleared FMX314 as the “world’s 1st single-port surgery solution compatible with standard 15mm laparoscopic trocar,” saying the device will reduce port-site complications and reduce post-operative pain. “We are very pleased […]
FDA adds new clearance for Cianna Medical’s Savi Scout breast cancer locator
Cianna Medical said today it won additional FDA 510(k) clearance for its Savi Scout radar localization breast cancer device, now cleared to be placed at the lumpectomy site up to 30 days prior to surgical removal. Aliso Viejo, Calif.-based Cianna’s Savi Scout is designed to produce audible and visual indicators surgeons can use to tag […]
FDA clears Centric Medical’s hammertoe device
Centric Medical, the foot & ankle division of Life Spine, said today it won FDA 510(k) clearance for its Hammertoe Correction System. The newly cleared system is designed to be inserted between the proximal and middle phalanges so opposing threads fixate on the phalangeal canal of the to to compress the joint, the Huntley, Ill.-based company said. “Due […]