Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements. “Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh […]
510(k)
Medtronic wins FDA nod for lower-profile HawkOne atherectomy device
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease. The Fridley, Minn.-based company’s HawkOne is a directional atherectomy device designed to treat severely calcified lesions in the blood vessels of the lower extremities. The device […]
FDA clears pediatric spine implants from Medicrea
Medicrea (EPA:ALMED) said today it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature patients. The New York City and Lyon, France-based company said it worked with a team of pediatric spinal surgeons to develop the low profile implants specifically designed […]
Philips wins FDA nod for Lumify S4-1 transducer
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for an S4-1 cardiac transducer for its Lumify smart-diagnostic ultrasound device. The newly cleared S4-1 transducer is pocket-sized and lightweight, Philips touted, designed to improve sensitivity and provide high-resolution 2D images. “Our vision for smart-device ultrasounds is focused on putting high-quality devices in the hands […]
Fresenius Kabi wins FDA nod for Aurora Xi plasmapheresis system
Fresenius Kabi (NYSE:FMS) said today that it won FDA 510(k) clearance for its Aurora Xi plasmapheresis system. Plasma, a component of blood that contains proteins, is used in therapies to treat burn victims, bleeding disorders, and other chronic and genetic problems. Patients who require plasma infusions or injections have to get them regularly and often […]
Viveve wins FDA 510(k) for its Viveve System
Viveve (NSDQ:VIVE) said today it won FDA 510(k) clearance for its Viveve System, now cleared for use in general surgical procedures for electrocoagulation and hemostasis. The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. “FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to […]
Becton Dickinson wins 510(k) for Vacutainer Barricor tubes
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its Vacutainer Barricor plasma blood collection tube. The Franklin Lakes, N.J.-based company touted improvements to the next-gen blood collection and separation device, saying its designed to improve sample quality, speed up result returns and improve patient care and clinical efficiency. “As we launch […]
Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as […]
Global Kinetics wins FDA nod for 2nd-gen wearable kinetigraph
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 […]
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 […]