Orthopedic robotic surgical platform developer Think Surgical said today it won expanded CE Mark approval in the European Union for its TSolution One surgical system, now cleared for use in total knee arthroplasty procedures. The TSolution One system is designed to aid in creating personalized pre-surgical joint replacement plans using CT-based 3D planning and and […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Boston Scientific wins FDA nod for Vercise DBS for treating Parkinson’s disease
Boston Scientific (NYSE:BSX) said yesterday it won FDA approval for its Vercise deep brain stimulation system designed to treat symptoms of Parkinson’s disease. The device, initially launched in Europe in 2012, was developed based on cochlear implant technology and is designed to stimulate a targeted region of the brain through implanted leads powered by an implantable pulse […]
FDA announces new alternative voluntary med device regulatory pathway
FDA Commissioner Dr. Scott Gottlieb today announced plans to add a new voluntary alternative pathway for medical devices which would allow clearance upon demonstration equivalence by meeting objective safety and performance criteria. Under the new framework, device manufacturers would be asked to meet objective criteria based on FDA-developed standards or guidance documents which “embody the […]
SetPoint Medical wins FDA IDE trial nod for rheumatoid arthritis implant trial
SetPoint Medical said today it won FDA investigational device exemption clearance to launch a trial of its proprietary bioelectronic device designed to treat patients with drug refractory rheumatoid arthritis. The device is designed to be surgically placed on the vagus nerve to activate the body’s natural inflammatory reflex, the Valencia, Calif.-based company said. “We are ready to […]
FDA approves Sanofi’s short-acting insulin lispro injection
The FDA today approved Sanofi‘s (NYSE:SNY) Admelog insulin lispro injection. The product is indicated to help adults and kids with Type I and Type II diabetes control their blood sugar levels. Admelog is the first short-acting insulin approved using the FDA’s 505(b)(2) pathway. Get the full story at our sister site, Drug Delivery Business News.
Intersect ENT wins FDA nod for Sinuva polyp-disease-treating sinus implant
Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]
7 medtech stories we missed this week: Dec. 8, 2017
From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press release that it has signed its first European distribution deal with Italian company Moss […]
Novaliq’s NovaTears, Omega-3 combo approved in Europe for evaporative dry eye disease
Privately-held pharma company Novaliq GmbH said this week that its NovaTears+Omega-3 combo therapy for patients with evaporative dry disease was registered in Europe. The treatment uses Novaliq’s water-free EyeSol drug delivery tech and is available in a multi-dose bottle. The company touted its product as the first eye drop to contain high concentrations of Omega-3 ethyl ester. […]
Acorda resubmits NDA for inhaled Parkinson’s disease therapy
Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. Get the full story at […]
Varian Medical wins Brazilian regulatory nod for Halcyon system
Varian Medical (NYSE:VAR) said today it won Brazilian ANVISA clearance for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system. The Palo Alto, Calif.-based company said its Halcyon IMRT system features improvements that make it more comfortable for patients and streamline operator’s workflow, only requiring nine steps from start to treatment, down from 30 steps in […]
Sunovion wins FDA nod for inhaled COPD therapy
The FDA has approved Sunovion Pharmaceutical‘s Lonhala Magnair system for the long-term treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today. The drug-device combo, also known as Sun-101/eFlow, is the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable nebulizer […]