China-based Viatom Technologies won FDA 510(k) clearance for its Checkme Pro mult-diagnostic device, according to an FDA filing posted last week. The ‘tricorder’ style device performs pulse oximetry, single-lead ECG recording, temperature measurement, sleep monitoring and movement sensing, according to the company’s site. The equipped ECG tracks heart rate, QRS duration, ST Segment and rhythm […]
510(k)
Svelte Medical granted CE Mark for Slender IDS drug-eluting stent catheter
Svelte Medical Systems said today it won CE Mark approval in the European Union for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system designed to treat coronary artery disease. The Slender IDS is the lowest-profile drug-eluting stent on the market, according to the New Providence, N.J.-based company. Approval in the EU came based on data […]
BTG wins FDA 510(k) for radiopaque beads, touts PneumRx coil study
BTG said today it won FDA 510(k) clearance for its LC Bead Lumi radiopaque embolic beads designed for embolization of hypervascular tumors and arteriovenous malformations and touted results from the Renew study of its PneumRx endobronchial coil implant. The Lumi was designed with radiopacity tech that allows for real-time tracking of bead location during embolization procedures, London-based BTG […]
CareFusion wins dual FDA 510(k) for vertebral balloons
Becton Dickinson & Co. (NYSE:BDX) subsidiary CareFusion said today it won FDA 510(k) clearances for 2 sizes of vertebral balloon systems designed for spinal augmentations. The company received clearance from the FDA for its 13-gauge AVAmax and 11-gauge AVAflex vertebral balloon systems for treating vertebral compression fractures. “We are committed to investing in research and development […]
Stimwave wins FDA 510(k) for SCS device
Stimwave Technologies said it won FDA 510(k) clearance for its Stimwave Freedom-8A 8-electrode wireless neuromodulation spinal cord stimulation device for relieving chronic back and leg pain. The Fort Lauderdale, Fla.-based company said it is the 1st wireless, fully programmable SCS neuromodulation device available. Stimwave said it has begun commercialization of the device and began implantation […]
FDA clears RevMedX wound dressing for civilian use
The FDA said today granted RevMedX’s XStat 30 wound dressing expanded 510(k) clearance to include adults and adolescents in the general population from an indiction of military use only. The XStat 30 wound dressing is an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed, the […]
Qfix wins FDA 510(k) for SRS immobilization device
Radiotherapy patient positioning device manufacturer Qfix said today it won FDA 510(k) clearance for its Encompass stereotactic radiosurgery immobilization system. The Encompass imobilization system uses posterior thermoplastic and an anterior open view mask that is compatible with optical tracking systems to allow for sub-millimeter accuracy and immobilization during stereotactic radiosurgery, the Avondale, Penn.-based company said. […]
FDA clears Philosys Gmate glucometer for Android
Medical and diagnostic device developer and manufacturer Philosys said today it won FDA 510(k) clearance for its Gmate Smart blood glucose monitoring system and associated application for Google (NSDQ:GOOG) Android devices. The Gmate Smart is designed to plus into the headphone jack on compatible smartphones to provide blood glucose test results, the New York-based company […]
PAD: Boston Scientific wins FDA, CE Mark nods for thrombectomy catheter
Boston Scientific (NYSE:BSX) said yesterday it won both FDA premarket approval and CE Mark approval in the European Union for its AngioJet ZeltanteDVT thrombectomy catheter designed to treat deep vein thrombosis. The ZelanteDVT is the 1st AngioJet catheter from Marlborough, Mass.-based Boston Scientific specifically designed to treat deep vein thrombosis, specifically in large-diameter upper and lower […]
Angiodroid yanks 510(k) over FDA CO2 clearance issue
ADM Tronics Unlimited said last Friday Angiodroid Americas withdrew its FDA premarket notification 510(k) application for the Angiodroid CO2 injector for angiography over lack of clearance for CO2 related to the indication. The Angiodroid device is an automatic injector for peripheral angiography that used CO2 gas which the company claims eliminates issues with iodine contrast medium […]
Visaris Americas wins FDA 510(k) for radiology and PACS suite
Digital imaging solutions company Visaris Americas said yesterday it won FDA 510(k) for its portfolio of software, flat panel detectors and various hardware offerings. The company’s central Avanse technology is designed to integrate with latest-generation flat panel detectors, which Visaris said enables facilities to transition to a single software platform to reduce cost and training […]