Royal Philips (NYSE:PHG) announced today that it launched its Quicklear mechanical thrombectomy system in the U.S. after receiving FDA clearance. QuickClear is a compact, single-use system designed to provide an all-in-one aspiration pump and catheter for removing blood clots from the vessels of the peripheral arterial and venous systems. It is now available for sale in […]
510(k)
Pentax launches high-def bronchoscopes in U.S.
Pentax Medical announced today that it launched its EB-J10 Series bronchoscopes in the U.S. after receiving FDA 510(k) clearance. The Hoya (TYO:7741) subsidiary’s EB-J10 Series bronchoscopes are designed to provide high-definition visualization of the bronchus and have compatibility with the simultaneously launched Defina video processor for supporting pulmonology practices with advanced imaging. Montvale, N.J.-based Pentax’s EB-J10 […]
410 Medical wins expanded clearance for LifeFlow device
410 Medical announced that it received FDA 510(k) clearance for its LifeFlow device in the rapid delivery of blood and blood components. Durham, N.C.-based 410 Medical’s LifeFlow device is a rapid infuser designed to deliver one liter of crystalloid fluid through a 20-gauge IV catheter in five minutes for front-line treatment of patients needing urgent […]
Varian wins FDA clearance for cancer therapy software
Varian Medical Systems (NYSE:VAR) announced that it received FDA 510(k) clearance for its Eclipse v16.1 treatment planning software. Palo Alto, Calif.-based Varian’s Eclipse V16.1 software is designed to enhance the visibility of soft tissue and provide more accurate information about tissue density, allowing dosimetrists to plan more precisely as they go about performing proton therapy, according […]
ControlRad wins FDA nod for radiation reduction technology
ControlRad announced today that it received FDA 510(k) clearance for the use of its ControlRad Trace on OEC 9900 Mobile C-arms. Atlanta-based Controlrad’s Trace system is designed for reducing radiation in fluoroscopically guided procedures. According to a news release, the ControlRad Trace can be retrofitted onto existing mobile C-arms with its proprietary semi-transparent filter, tablet […]
B-Temia wins FDA clearance for mobility exoskeleton
B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system. Short for “keep on going,” Keeogo is a lower-limb-powered human mobility device with Dermoskeleton lightweight exoskeleton technology that provides what the Quebec City-based company describes in a news release as a “true human-machine interface.” The Keeogo Dermoskeleton is designed […]
Fitbit wins U.S., EU regulatory approval for ECG app
Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app. San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release. The Fitbit […]
Minnetronix Medical wins FDA clearance for neurosurgical access port
The FDA has cleared Minnetronix Medical‘s MindsEye neurosurgical access port for deep brain surgeries, the company announced today. The clearance represents an expansion beyond the St. Paul, Minn.–based contract manufacturer’s traditional offerings. “This extension of our business represents an additional way to partner with customers. We have the opportunity to offer them products they can […]
FDA clears SurGenTec synthetic bone graft
SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic bone graft. Boca Raton, Fla.-based SurGenTec said in a news release that its novel OsteoFlo NanoPutty bone graft features the world’s first and only quadphasic synthetic bone graft particles with nano-surface technology for providing an “optimal resorption profile with […]
FDA clears ClearMask transparent surgical mask
ClearMask announced today that it received FDA 510(k) clearance for its ClearMask fully transparent surgical mask for use in a number of settings. Baltimore-based ClearMask touts its surgical mask as the first FDA-cleared fully transparent surgical mask for use in hospitals, clinics, schools, retail, hospitality and other settings. The company said in a news release […]
FDA gives additional OK to point-of-care MRI
Hyperfine Research Inc. will begin rolling out a commercial launch for its Swoop Portable MR imaging device after receiving an additional 510(k) approval from the FDA, which will permit the system to be used on newborns and infants. In a release, the Guilford, Conn.-based company defines Swoop as a “point-of-care MR imaging device that wheels […]
