BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system. The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The newly cleared system is intended to reduce […]
7D Surgical wins FDA nod for MvIGS nav system Cranial Module
Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system. The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms. The system’s navigation technology is embedded in an overhead surgical light […]
Endologix pushes Nellix release timeline to 2021
Endologix (NSDQ:ELGX) said it doesn’t expect to receive FDA premarket approval for its Nellix 3.5 endovascular sealing system until 2021. The Irvine, Calif.-based company this week updated on its estimated timeline for anticipated FDA approval, saying it expects to land premarket approval for the Nellix stent graft by the first half of 2021. The forecast is […]
UK’s MHRA details what medtech should expect during Brexit
The UK’s Medicines and Healthcare products Regulatory Agency today released an update on what medtech and pharmaceutical companies can expect to see as the country begins to implement plans to split from the European Union. The Brexit agreement implementation period is set to end on December of 2020, according to the notice, during which the […]
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 […]
FDA approves Ivantis’ Hydrus microstent
Ivantis said today it won FDA approval for its Hydrus microstent designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large […]
GI Dynamics wins FDA nod for pivotal US EndoBarrier trial
GI Dynamics (ASX:GID) said today it won FDA investigational device exemption approval to launch a pivotal trial of its EndoBarrier device designed for treating patients with type 2 diabetes and obesity, pending Institutional Review Board approval. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and […]
J&J’s Cerenovus wins CE Mark for Bravo flow diverter
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said this week it won CE Mark approval in the European Union for its Bravo flow diverter designed to treat intracranial aneurysms. The newly cleared device is designed to divert blood flow from aneurysms to promote healing and reduce the risk of rupture, the company said. The Bravo is Cerenovus’ first flow […]
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 […]
Boston Scientific to submit last FDA PMA module for Lotus Edge aortic valve this month
Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week. The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years. […]
ARTMS’ system may ease cost, shortage of valuable radioisotopes
ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons. Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear […]
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