The first patient with drug-resistant epilepsy has received LivaNova’s (NASDAQ:LIVN) vagus nerve stimulation (VNS) therapy system, kicking off enrollment of a global registry to evaluate it, the company said. Drug-resistant epilepsy (DRE) affects nearly one in three people with epilepsy, according to an article in the New England Journal of Medicine. The LivaNova study will […]
Implants
Study slams FDA’s ‘fast-track’ approval process
More than 98% of the 161 foot and ankle implants that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process allows […]
Envoy Medical’s hearing implant wearers can get MRIs
The FDA has given Envoy Medical’s landmark Esteem middle-ear implant clearance for MR-conditional labeling in both 1.5 and 3.0 Tesla (T) scanning environments. White Bear Lake, Minn.-based Envoy introduced the Esteem — the first fully implantable device to treat hearing loss in the U.S. — in 2010. Surgeons and audiologists who work closely with hearing […]
Tackling drug delivery challenges with TissueGen’s implantable fibers
TissueGen‘s chief scientist and co-founder, Kevin Nelson, told Drug Delivery Business News the story behind the company he founded in 2000 and its drug delivery technology, the Elute fiber. DDBN: How did TissueGen get its start? Nelson: In 1996, while faculty in biomedical engineering at The University of Texas at Arlington, I was working with […]
Intersect ENT shares tumble on Q2 results
Shares in Intersect ENT (NSDQ:XENT) fell today after the medical device maker missed sales expectations on Wall Street with its second-quarter financial results. The Menlo Park, Calif.-based company posted a net loss of -$4.2 million on sales of $26.3 million for the 3 months ended June 30, for sales growth of 9.7% compared with the same period […]
CarboFix wins FDA nod for its carbon/PEEK pedicle screws
CarboFix Orthopedics Ltd. has won FDA approval for a spinal screw system for use in people with advanced spinal cancer. The CarboClear carbon fiber pedicle screw system was designed to restore the integrity of the spinal column, even in the absence of fusion, for a limited time period in patients with advanced-stage thoracic and lumbar spine […]
FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set to […]
New robot takes on repetitive hair-restoration tasks
Restoration Robotics (NASDAQ:HAIR) has launched a robotic intelligent system that offers precise, minimally invasive, repeatable hair harvesting and implantation uses in one platform. The Artas iX robotic hair restoration system has a 3-camera stereoscopic vision system with 44-micron resolution and a 7-axis robot. It has a compact, motorized, battery-powered, portable and adjustable procedure chair for increased patient comfort and […]
Breast implant makers Polytech, G&G ink stock-swap merger pact
Silicone breast-implant makers Polytech Health & Aesthetics and G&G Biotechnology are getting together in a stock-swap merger. G&G designed the world’s first lightweight breast implant, the B-Lite, to reduce the impact of gravity on the reconstructed or augmented breast using technology developed by NASA to make its implants up to 30% lighter. The company sells its products in […]
5 medtech stories we missed this week: July 6, 2018
From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Zetta wins FDA clearance for Zoom MRI software Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known […]
8 Alzheimer’s disease breakthroughs you need to know
Alzheimer’s is a form of dementia that can cause problems with memory, thinking and behavior, according to the Alzheimer’s Association. It is the most common form of dementia that gets worse over time. Nearly 6 million Americans presently live with Alzheimer’s— and there’s no cure for it. The disease is caused by protein buildups […]