Adhezion Biomedical said today it won FDA 510(k) clearance for its SecurePortIV catheter securement adhesive. The Wyomissing, Penn.-based company said the SecurePortIV adhesive can be used with short-term or long-term vascular access devices to improve securement, seal catheter insertion sites, protect from catheter related blood stream infections and provide a water-resistant barrier. “SecurePortIV is the only […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Nexxt Spine wins FDA nod for Nexxt Matrixx interbody, VBR devices
Nexxt Spine said today it won FDA 510(k) clearance for its Nexxt Matrixx platform of interbody and vertebral body replacement devices. The Noblesville, Ind.-based company said the Nexxt Matrixx system is composed of porous titanium devices designed with open architectural porosity, residue-free surface tech and “robust radiographic imaging performance.” “The Nexxt Matrixx system applies breakthrough […]
FDA expands protocol for investigational ReCell burn injury device
Avita Medical (ASX:AVH) said today that the FDA approved a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device. The approved treatment protocol for burn injuries has been simplified, according to the company, and the number of approved investigational sites has grown from eight to 15. Get the full story at […]
CartiHeal launches pivotal trial of Agili-C knee implant
CartiHeal said yesterday it launched an FDA investigational device exemption clinical study of its Agili-C implant for repairing cartilage, osteochondral defects and treating joint surface lesions. A total of 16 patients have been enrolled and undergone operations at European centers in the trial, the Israel-based company said. The 2-year, 250-patient pivotal study will engage US and […]
FDA unveils new search tool for Adverse Event Reporting System
The FDA said this week it launched a new search tool for its adverse event reporting system dashboard to allow users to access reports of adverse drug reactions. FDA Commissioner Dr. Scott Gottlieb said the changes are intended to “better inform patients and health care professionals of adverse events reported with drug and biologic products.” […]
7 medtech stories we missed this week: Sept. 29, 2017
From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EOI wins FDA nod for FLXfit15 expandable cage EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance […]
Novo Nordisk wins FDA nod for fast-acting mealtime insulin
Novo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection. The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported. Get […]
Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem
Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership. Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger […]
FDA warns on endoleaks with stent grafts
The FDA yesterday warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta. The federal safety watchdog said the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent […]
Avita Medical submits PMA app for ReCell burn injury treatment
Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device. The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments. Get the full story at our sister site, Drug Delivery Business News.
Avinger wins CE Mark for in-stent restenosis indication for image-guided atherectomy
Avinger (NSDQ:AVGR) said today that it won CE Mark approval for treating in-stent restenosis with its Pantheris Lumivascular atherectomy system. The company’s Lumivascular tech enables physicians to see from inside the artery during a directional atherectomy procedure in real-time, Avinger touted, using optical coherence tomography. The device is designed to help physicians more accurately navigate their […]