Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. Get the full story […]
Medtronic launches Envision Pro CGM in Europe
Medtronic (NYSE:MDT) said today that its Envision Pro continuous glucose monitoring system received CE Mark approval and will be commercialized in Europe and the Middle East this fall. The Envision Pro CGM is designed to provide blinded glucose levels, track events and compile reports for physicians to assess therapies. The CGM collects glucose data to generate […]
Biotronik taps Proximo Medical for U.S. peripheral debut
Biotronik tapped Proximo Medical to guide the U.S. commercialization of its peripheral vascular intervention platform. The German medtech maker’s PVI line includes the Pulsar and Astron stents, the Passeo PTA balloon catheter and Fortress introducer sheath. Castle Pines, Colo.-based Proximo provides market research services to medical device, venture capital and private equity companies. “By partnering […]
Philips wins $400m Pentagon deal for PACs imaging system
Philips Healthcare Informatics, a branch of Royal Philips (NYSE:PHG), won a $400 million contract from the U.S. Defense Dept. last week for its digital imaging network picture archiving communications system. The fixed-price, indefinite-delivery/indefinite-quantity contract has a five-year base with one five-year option period. Ten offers were received for the acquisition. Philips’ PACs will be used by […]
FDA clears Rex Medical’s Revolution peripheral atherectomy device
Rex Medical said last week that it received FDA 510(k) clearance for its Revolution peripheral atherectomy system. The Conshohocken, Pa.-based company’s Revolution device is indicated for atherectomy of the peripheral vasculature and is designed to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease. In the 121-person Reveal IDE […]
Profound Medical inks $8m private placement deal
Profound Medical (TSX:PRN) last week grossed nearly $8 million from a private placement with a pair of investment banks. Mississauga, Ontario-based Profound, which developed the Tulsa-Pro MR-guided prostate ablation device, said it sold a total of 9.1 million units at 83¢ (C$1.10) apiece to Canaccord Genuity and Echelon Wealth Partners for gross proceeds of about $7.5 […]
Varian backs Oncora, launches Ethos radiotherapy device
Varian Medical (NYSE:VAR) said last week that it invested an unspecified amount in Oncora Medical and launched its Ethos artificial intelligence radiotherapy device. Philadelphia-based Oncora makes software used to plan radiotherapy procedures. Palo Alto, Calif.-based Varian said the partnership with Oncora is aimed at accelerating its software development for radiation oncology. “We envision a world where all […]
FDA clears Zimmer Biomet’s JuggerStitch meniscal repair device
Zimmer Biomet (NYSE:ZBH) said today that it received FDA 510(k) clearance for its JuggerStitch meniscal repair device. The JuggerStitch implant consists of two soft anchors connected by a knotless, self-locking suture loop, instead of a traditional implant using a sliding knot to lock the repair. The Warsaw, Ind.-based company said the device is designed to improve […]
Gala Therapeutics wins FDA breakthrough nod for RheOx
Gala Therapeutics said today that it won breakthrough device designation from the FDA for its RheOx bronchial rheoplasty device for patients with chronic bronchitis. Menlo Park, Calif.-based Gala’s RheOx system is designed for the minimally invasive delivery of non-thermal energy to airways, reducing mucus-producing cells associated with chronic bronchitis. Current treatments target bronchodilation and inflammation […]
Abbott wins FreeStyle Libre reimbursement in Ontario, Quebec
Abbott (NYSE:ABT) said today that it has won public reimbursement in Ontario and Quebec for its FreeStyle Libre sensor-based glucose monitoring system — the first of its kind listed by any provincial health plan in Canada. FreeStyle Libre is designed to monitor glucose levels with a small sensor on the back of the upper arm […]
Wallaby Medical wins FDA nod, CE Mark for Avenir neurovascular coil
Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil system for intracranial aneurysms and other neurovascular abnormalities. The Laguna Hills, Calif.-based company also said it inked an exclusive distribution deal with Phenox for the commercialization of Avenir in the U.S. and Europe. […]
