We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Edwards Lifesciences says that a clinical trial found favorable patient outcomes after six months for its investigational Evoque transcatheter, transfemoral, tricuspid valve-replacement system. Read More
Swiss company Alcon is paying $475 million to acquire device company Ivantis, developer of the Hydrus Microstent for surgical glaucoma, strengthening Alcon’s ophthalmology portfolio. Read More
A bipartisan group of 10 senators has asked the Centers for Medicare & Medicaid Services (CMS) to find a way to pay for breakthrough devices, after the agency withdrew its previous proposal to do so. Read More
Abbott’s MitraClip G4 reduced mitral regurgitation (MR) in a clinical trial to one or fewer in 91 percent of patients and significantly improved their New York Heart Association classification and quality of life, the company said last week. Read More
Penumbra’s Indigo System CAT RX catheter met the primary endpoint in the “Cheetah” postmarket clinical study, demonstrating high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention in patients with high thrombus burden, the company said Friday. Read More
Despite pleas for approval during a public comment period, the FDA’s Psychopharmacologic Drugs Advisory Committee failed yesterday by a vote of 12-to-1 to recommend Levo Therapeutics’ intrasanal carbetocin — an oxytocin analogue delivered via a spray pump — for treatment of hyperphagia and related anxiety in children with a rare genetic disorder, Prader-Willi Syndrome. Read More
Device sponsors who want to supply real-world data to the FDA to support a product application need to consider how it can answer a specific regulatory question, advised Kristin Zielinski Duggan, partner at the law firm Hogan Lovells, in an FDAnews webinar. Read More
Outset Medical has received the first-ever approval under new Medicare rules that allow the federal program to pay for innovations in dialysis. Read More
After mulling mountains of data on Endologix’s AFX2 endovascular graft, an expert panel of the FDA’s Medical Devices Advisory Committee came to an unofficial conclusion: The stent — which has had a troubling propensity to fail — may be a good option in some small niche populations, but it’s not suitable for use in broad populations. Read More
Sponsors of some types of device software should file “enhanced documentation” as part of premarket submissions, the FDA says in a draft guidance released yesterday. Read More
The European Commission aims to increase the availability of notified bodies and designate EU reference laboratories as “essential actions” needed to ensure that the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) can take effect as planned on May 26, 2022. Read More