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 […]
Food & Drug Administration (FDA)
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 […]
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.
Haemonetics wins FDA 510(k) for NexSys PCS plasmapheresis system
Haemonetics (NYSE:HAE) said today it won FDA 510(k) clearance for its NexSys PCS plasmapheresis system designed for collecting blood plasma. The NexSys PCS includes bi-directional connectivity to the Braintree, Mass.-based company’s NexLynk DMS donor management system, and allows for automated collection procedure programming and automated end of procedure documentation. “NexSys PCS is designed to increase productivity […]
7 medtech stories we missed this week: July 28, 2017
From Accenture’s AI-powered app to help the visually impaired to Rayovac getting clearance from Health Canada, here are seven medtech stories we missed this week but still thought were worth mentioning. 1. Accenture touts AI-powered app for visually impaired Accenture announced in a July 28 press release that it has developed an artificial intelligence–powered way to […]