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 […]
510(k)
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 […]
Accuray wins CE Mark for Radixact platform
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 […]
FDA releases updated draft guidance on 510(k) modification submissions
The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market.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 […]