HeartWare lands approval for a 4th round of pivotal trials for its HVAD ventricular assist device
Regulatory Roundup
Medtronic wins Canadian approval for brain-stim therapy for epileptics | Regulatory Roundup
Breast implants: FDA clears new silicon implant despite consumer protests | Regulatory Roundup
Diabetes: Abbott lands FDA win for touch-screen glucose monitor | Regulatory Roundup
FDA to begin collecting data for med-tech shortage database | Regulatory Roundup
BSX launches Promus Element stent in Japan | Regulatory Roundup
FDA nod for Hologic’s NovaSure buoys rival Conceptus | Regulatory Roundup
Toshiba lands 510(k) for latest Aquilon CT scanner | Regulatory Roundup
Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.
The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.
Boston Scientific lauds NICE results from the U.K. | Regulatory Roundup
Boston Scientific Corp. (NYSE:BSX) lauded a new guidance released by the research arm of the U.K.’s National Health Service, the country’s publicly funded health care system.
The National Institute for Health & Clinical Excellence issued a final guidance for bronchial thermoplasty as an option for patients with severe asthma that isn’t controllable with drugs, a boon for Boston Scientific’s Alair.
Medtronic enrolls first patient in Fire & Ice ablation study | Regulatory Roundup
Medtronic (NYSE:MDT) enrolled the first of up to 572 patients in its Fire & Ice trial, the largest clinical study to date to compare 2 atrial fibrillation ablation systems.
Medtronic wins 510(k) for surgical sealer | Regulatory Roundup
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.