US Senators today voted to pass the FDA’s Reauthorization Act of 2017 to reauthorize the FDA’s user fee program, sending the bill on to the President’s desk to sign. The FDA Reauthorization Act renews an existing law that expires on Sept. 30 and which provides the majority of FDA funds used to regulate pharmaceuticals and […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Medical device labeling: You need to design it, too
When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston. Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives […]
Laminate Medical wins FDA IDE nod for VasQ fistula device trial
Laminate Medical Technologies said this week it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support […]
Medtronic wins FDA nod, CE Mark for Avalus aortic valve
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union and FDA approval in the US for its Avalus pericardial aortic surgical valve designed to treat aortic valve disease. The Avalus is the Fridley, Minn.-based company’s next-gen pericardial surgical aortic valve, and features a supra-annular design to improve hemodynamic performance and limit central […]
Ocular Therapeutix slashes workforce following FDA rejection
Ocular Therapeutix (NSDQ:OCUL) revealed yesterday that it plans to cut 26 jobs across the Bedford, Mass.-based company – about 19% of its workforce. The effort to reorganize comes just weeks after the FDA rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza. Get the full story at our sister site, Drug Delivery Business News.
EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device
Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device. The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate […]
LivaNova wins MRI-safe CE Mark for VNS Therapy systems
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark approval in the European Union for its Vagus Nerve Stimulation Therapy systems, now labeled as safe for 1.5T and 3T magnetic resonance imaging scans. The labeling change for the London-based medical device maker includes its AspireHC and AspireSR devices, allowing patients with existing devices to safely have MRI […]
Japan clears CardioFocus’ HeartLight
CardioFocus said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its HeartLight endoscopic ablation system with an indication for treating paroxysmal atrial fibrillation. The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with […]
Accuray wins FDA nod for iDMS data management system
Accuray (NSDQ:ARAY) said today it won FDA 510(k) clearance for its iDMS data management system designed for sharing data between the company’s treatment delivery platforms. The Sunnyvale, Calif.-based company said the iDMS system is designed to integrate data from its technology platforms, including the Radixact, TomoTherapy and CyberKnife systems, as well as the company’s Accuray Precision […]
FDA grants priority review to Indivior’s monthly buprenorphine depot
Indivior (LON:INDV) said today that the FDA accepted the new drug application for its once-monthly injectable buprenorphine depot as a treatment for adults with opioid use disorder. The regulatory agency also granted priority review designation to the company’s NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy of […]
Injectable, extended-release bipolar drug wins FDA nod
Otsuka Pharmaceutical (TYO:4578) and Lundbeck said last week that its extended-release injectable aripiprazole suspension, Abilify Maintena, won FDA approval as a maintenance monotherapy for adults with bipolar I disorder. The once-monthly intramuscular formulation was created by Otsuka and co-developed and commercialized with Lundbeck, the companies reported. Get the full story at our sister site, Drug Delivery Business News.