Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley, N.Y.-based company. The investigational drug is designed to treat people with Parkinson’s disease who are experiencing “off” periods, or a re-emergence of symptoms. Get the full story at our sister site, Drug […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
EU committee backs dosing changes for Bristol-Myers Squibb’s immunotherapy
A committee for the European Union’s pharmaceutical regulatory agency backed changes to the dosing schedule for Bristol-Myers Squibb‘s (NYSE:BMY) Opdivo cancer drug, the company touted today. The Committee for Medicinal Products for Human Use recommended that the European Commission approve a dosing schedule of 480-mg infused over 60 minutes every four weeks as an option for […]
UPDATE: Moll’s Auris wins FDA nod for Monarch robotic endoscopy platform
Updated to include commentary from Auris chief strategy officer Josh DeFonzo. Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform. The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on […]
7 medtech stories we missed this week: March 23, 2018
From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]
Smiths Medical touts FDA nod, US launch of DeltaVan cath
Smiths Medical today touted the FDA clearance and US launch of Delta Med’s DeltaVan closed system catheter. The DeltaVen device is a next-gen peripheral IV catheter which offers the needle, extension tubing and an options for a needleless connector. Smiths Medical said it will be available immediately in a variety of sizes and configurations. Minneapolis, […]
BD finds chemical from blood collection tube interferes with Magellen lead test
Studies conducted by Becton Dickinson (NYSE: BDX) found that a chemical present in its Vacutainer blood collection tubes interfered with lead tests made by Magellan Diagnostics. The FDA first warned consumers in May of 2017 that Magellan’s lead tests may provide inaccurate results when used with blood drawn from the vein and held in BD’s blood collection […]
MIS device startup Human Xtensions wins FDA nod for HandX device
Minimally invasive surgery device start up Human Xtensions said today it won FDA 510(k) clearance for its HandX device. The HandX device is a light-weight, handheld device designed to translate a surgeon’s natural hand motions into more complex movements inside the patient, the Israel-based company said. The device is part of a series of electromechanically-simplified […]
FDA’s CDRH to expand Digital Health Pre-Cert program
The FDA’s Center for Devices and Radiological Health is looking to expand its digital health pre-certification pilot program by the end of 2018, according to a report from the Regulatory Affairs Professionals Society. Testing is slated to continue on the pilot program through to December with more participants joining the initial nine selected last December, […]
Nevro wins FDA nod for MRI-conditional labeling on Senza SCS
Nevro (NYSE:NVRO) said yesterday that the FDA approved MRI-conditional labeling for its Senza spinal cord stimulation system designed to deliver HF10 therapy. The Redwood City, Calif.-based company said that with the labeling expansion, its devices are now cleared as MRI-safe in all its markets. The approval is retroactive, the company added, applying to all patients implanted with […]
Japan approves Novo Nordisk’s once-weekly Type II diabetes drug
The Japanese Ministry of Health, Labor and Welfare gave Novo Nordisk (NYSE:NVO) the green light to market its once-weekly type II diabetes drug, Ozempic, Reuters reported today. The pharma company’s drug, semaglutide, is a glucagon-like peptide-1 analog that mimics an intestinal hormone to trigger insulin production in people with diabetes. Get the full story at our sister site, Drug Delivery […]
FDA pulls select Monteris Medical NeuroBlate systems in Class I recall
The FDA today issued a recall for select Monteris Medical NeuroBlate systems and laser delivery probes over issues with unexpected MRI-related heating and damage to the tip of the probe that could cause serious injuries. The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential […]