Accuray (NSDQ:ARAY) said today it won CE Mark approval in the European Union for its Radixact treatment delivery platform designed for image-guided radiotherapy treatments designed for cancer patients. Clearances include the Radixact treatment delivery system, Accuray Precision treatment planning system and iDMS data management system, the Sunnyvale, Calif.-based company said. “Radixact System availability in the EU […]
510(k)
FDA releases updated draft guidance on 510(k) modification submissions
The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market. The recommendations cover how manufacturers should consider the risk of device modifications when determining whether they need to submit a new 510(k) application, and will replace guidance that is 19 […]
Fujifilm wins FDA nod for digital radiography suite
Fujifilm Medical Systems (TSE:4901) said today it won FDA 510(k) for its digital radiography FDR Visionary Suite and FDR Clinica X-ray components. The new Visionary Suite X-ray system is designed for mid-to-large hospitals and health systems, while the FDR Clinica X-ray components were designed for outpatient facilities, FujiFilm said. “We take great pride in our ability […]
Micro Interventional Devices wins FDA nod for Permaseal
Micro Interventional Devices said today it won FDA 510(k) clearance for its Permaseal transapical access and closure device. The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology. “The FDA market clearance of Permaseal is another tremendous […]
SPR Therapeutics wins FDA nod for peripheral nerve stim pain relief device
Pain management company SPR Therapeutics yesterday said it won FDA 510(k) clearance for its Sprint peripheral nerve stimulation system designed to provide chronic pain relief. The Cleveland, Ohio-based company touted the Sprint system as the 1st reversible and minimally-invasive PNS to win FDA clearance for treating chronic and acute pain, including post-operative and post-traumatic pain. […]
Companion Medical wins FDA nod for InPen insulin pen
Companion Medical said today it won FDA 510(k) approval for its wireless-enabled InPen insulin pen and mobile application. The InPen is designed to connect to smartphones via bluetooth and send data back, including insulin dosage and timing, the company said. The app allows patients to track and calculate doses, and set alarms for future doses. […]
FDA clears U.K. start-up Cydar’s surgical guidance software
The FDA last week cleared U.K.-based imaging and guidance developer Cydar EV‘s surgical guidance software designed for X-ray guided vascular surgery. The Cydar EV guidance system uses fully-automatic computer vision to track patients during X-ray guided surgery, allowing the combination of diagnostic scanning, planning information and real-time imaging, the company said. “This FDA clearance is […]
Tandem Diabetes wins pediatric indication for t:slim insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) said today it won FDA 510(k) clearance for an expanded pediatric indication for its t:slim insulin pump, now indicated for use in children 6 and older. The San Diego, Calif.-based company said the expanded indication applies to its current t:slim pump features and that there were no changes made to the existing user […]
Syneron Medical wins FDA 510(k) for short-wavelength PicoWay laser
Syneron Medical said today it won FDA 510(k) clearance for a new ultra-short 785nm wavelength laser for its PicoWay picosecond laser device. The PicoWay system is an aesthetic laser system designed for removing tattoos of all colors and types and treating pigmented lesions. The system won FDA clearance for the removal of tattoos in November, […]
Relievant Medsystems wins FDA clearance for Intracept ablation device for low back pain
Relievant Medsystems said today it won FDA 510(k) clearance for its Intracept intraosseous nerve ablation system designed for the treatment of chronic lower back pain. The company touted the system as the 1st specific therapy to relieve chronic lower back pain which has persisted for at least 6 months and not responded to conservative care […]
Medtronic wins 1st FDA nod for cement-augmented spine screws
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate fenestrated screw cement. The company touted the win as the 1st FDA approval for cement-augmented pedicle screws. The newly FDA cleared screw set is indicated for use at […]