Food & Drug Administration (FDA)
FDA chides AMRI for unapproved human trials of medical electromagnet
Updated February 28, 2014, at 10 a.m. with comments from AMRI.
FDA regulators had strong words for Advanced Magnetic Research Institute International following an inspection of the electromagnetic therapy center’s practices.
Carestream lands FDA nod for X-ray app on Apple, Samsung devices
Carestream Health said it landed 510(k) clearance from the FDA for its new Vue Motion mobile app for Apple and Samsung mobile device platforms.
The app gives physicians mobile access to X-ray exams using Apple’s iPhone 4 and iPad 2 devices, as well as the Galaxy Note and Galaxy S III devices made by Samsung.
Analysis of 24,000+ FDA 510(k) records reveals trends
By Stewart Eisenhart, Emergo Group
J&J’s Biosense Webster wins PMA nod from FDA for force-sensing catheter
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster subsidiary said it won pre-market approval from the FDA for its ThermoCool SmartTouch force-sensing ablation catheter, making it the 1st such device to hit the U.S. market.
Report: Fewer recalls, farther-reaching implications in Q4
AMIC looks to down-classify brachytherapy’s FDA status
Washington-based Advanced Medical Isotope Corp. is evaluating its options for U.S. market approval of its proprietary brachytherapy cancer product, the company announced.
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.