Washington-based Advanced Medical Isotope Corp. is evaluating its options for U.S. market approval of its proprietary brachytherapy cancer product, the company announced.
Food & Drug Administration (FDA)
FDA says ConMed has more work in addressing violations at Colorado plant
FDA warns Baxter on HomeChoice dialysis system, infusion pump
Report: FDA panel recommends Inspire Medical’s sleep apnea implant
Updated February 24, 2014, with details from Inspire Medical.
An expert panel of FDA advisors voted today to recommend approval for Inspire Medical’s sleep apnea implant, the Inspire II Upper Airway Stimulator, the company confirmed.
Interventional Spine wins expanded clearance for Opticage spine implant
Interventional Spine said it secured expanded 510(k) clearance from the FDA for its Opticage spine implant
The Irvine, Calif.-based company makes implants used in spine surgeries, with a focus on osteoporosis-afflicted bones. expandable interbody fusion device.
Smith & Nephew brings Polarstem cementless hip implant to the U.S.
Smith & Nephew (FTSE:SN, NYSE:SNN) said it’s launching its Polarstem cementless hip stem in the United States for total hip replacement procedures.
Medtronic lands U.S., E.U. wins for miniature cardiac monitor
FDA reviews adverse events, durability of Inspire Medical’s sleep apnea implant
Minnesota-based Inspire Medical Systems has a date with the FDA tomorrow, when the agency’s expert Anesthesiology & Respiratory Therapy Devices Panel will review data and make a recommendation on the Inspire II Upper Airway Stimulator.
Regulatory science supports FDA’s regulatory mission
By: Carolyn A. Wilson, Ph.D.
Admedus gains U.S. clearance for cardiovascular scaffold
Admedus won 510(k) clearance from the U.S. FDA for its CardioCel cardiovascular scaffold.
Perth, Australia and Minneapolis, Minn.-based Admedus is developing implantable regenerative technologies. CardioCel, the company’s 1st product, is a pure collagen, bio-compatible regenerative tissue scaffold.
Claret Medical lands FDA OK for U.S. trial of Sentinel cerebral protection device
Claret Medical is clear to launch a pivotal U.S. trial of its Sentinel cerebral protection system, having won FDA approval to evaluate the device in patients undergoing transcatheter aortic valve implantation.
The study is slated to begin in the 1st quarter of 2014 and will involve up to 15 clinical centers, Claret reported.