OrthoPediatrics this week announced it won FDA 510(k) clearance for its Femur pediatric nailing platform and released its first quarter earnings, beating sales consensus but missing on loss-per-share expectations on Wall Street. The Warsaw, Ind.-based company’s Femur system is designed to accompany two pediatric-specific nail offerings, and is an upgrade to an earlier version of the […]
510(k)
CurveBeam wins FDA 510(k) for LineUp standing CT scanner
Medical imaging device developer CurveBeam said today it won FDA 510(k) clearance for its LineUp multi-extremity weight bearing computed tomography system. The newly cleared system is designed for the 3D visualization of bone detail in the lower extremities while the patient remains standing so that the anatomy can be assessed while in load bearing positions, the […]
7 medtech stories we missed this week: May 11, 2018
From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau […]
7 medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed […]
FDA clears Mobius Imaging’s Airo Mobile CT imager for pediatric use
Mobius Imaging said yesterday it won FDA 510(k) clearance for its Airo Mobile CT imaging system designed for pediatric applications. The Shirley, Mass.-based company said it previously won FDA 510(k) clearance in 2013 for non-pediatric imaging, and is designed for use in applications supporting brachytherapy, radiation therapy and surgical imaging. The new clearance is an […]
Viz.ai wins FDA nod automated CT perfusion software
Artificial Intelligence healthcare developer Viz.ai said yesterday it won FDA 510(k) clearance for its Viz CTP computed tomography perfusion image processing and analysis software. The San Francisco-based company said that the software compliments its current offerings, which include automated large vessel occlusion stroke identification, stroke triage and LVO notification, patient selection, medical image viewing, transport coordination and […]
SurModics wins FDA nod for low-profile PTA balloon dilation catheter
SurModics (NSDQ:SRDX) said yesterday it won FDA 510(k) clearance for its .018″ low-profile percutaneous transluminal angioplasty balloon dilation catheter designed for peripheral vascular use. The newly cleared low-profile catheter features the Eden Prairie, Minn.-based company’s low-friction, low-particulate Serene hydrophilic coating with a range of between 2mm to 10mm. “We are delighted to announce this latest of three […]
Varian wins FDA nod for Calypso anchored beacon transponder for SBRT therapy
Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Calypso anchored beacon transponder designed for use with its TruBeam, Edge and Clinac C-series medical linear accelerators. The Calypso system and the anchored beacon transponder are designed to detect tumor movement to aid in the delivery of lung stereotactic body radiotherapy with more precision, […]
Arthrosurface wins FDA nod for OVOMotion shoulder arthroplasty system
Arthrosurface said yesterday it won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system. The Franklin, Mass.-based company said the newly cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis. “This truly is a revolutionary stemless […]
Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor
Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims. The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said. “We strive to deliver real life […]
Innovus Pharma wins FDA nod for glucose monitoring kit
Innovus Pharmaceuticals (OTC:INNV) said today that its GlucoGorx glucose monitoring kit, which includes a glucose meter, test strips and a lancet device, won 510(k) approval from the FDA. The San Diego, Calif.-based company plans to launch its blood sugar monitoring kit in the second half of this year. Get the full story at our sister site, […]