CorMatrix Cardiovascular said today that it won FDA investigational device exemption approval to launch an early feasibility study of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease. The Atlanta-based company touts its Cor Tricuspid valve as the first cardiac valve of its kind […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA clears Imperative Care’s stroke treatment catheters
Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters. Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke, and other brain blood-vessel […]
FDA clears Rebound Therapeutics’ minimally invasive neurosurgical endoscope
Rebound Therapeutics has secured FDA 510(k) clearance for its Aurora Surgiscope system, which it touts as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and illumination during neurosurgical procedures, the Irvine, Calif.–based company said yesterday. “Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any […]
Perspectum wins FDA nod for biliary duct mapping software
Perspectum Diagnostics said this week that it won 510(k) clearance from the FDA for its biliary visualization software, MRCP+. The company’s AI-powered software is designed to provide improved visualization, monitoring and reporting of intra-hepatic ducts. The metrics produced by MRCP+ could be particularly useful for doctors monitoring patients with primary sclerosing cholangitis, according to Perspectum […]
Applied Tissue Technologies’ negative-pressure dressing gets FDA nod
Wound-care company Applied Tissue Technologies said it has won FDA clearance of its negative-pressure wound therapy product, the Platform Wound Dressing (PWD). The class II device represents the first-of-its-kind embossed negative pressure wound therapy device to be used without foam or gauze, according to the Hingham, Mass. company. The PWD is a transparent dressing with […]
CE Mark suspended for Endologix Nellix stent graft
Endologix (NSDQ:ELGX) said yesterday that the CE Mark approval for its Nellix stent graft system designed for treating abdominal aortic aneurysms was suspended by its notified body, GMED. The move follows a halt to unrestricted sales of the stent grafts and a voluntary recall of all existing inventory that the Irvine, Calif.-based company announced earlier this month. […]
Boston Scientific’s Vici venous stent meets primary endpoints at 1 year
Boston Scientific (NYSE:BSX) today touted 12-month data for its Vici venous stent in people with significant obstructions in the illiofemoral venous outflow tract. Researchers reported that the Vici stent met its primary efficacy endpoint with a primary patency rate of 84% at one year. Nearly 99% of people treated with the Vici stent were free from […]
FDA clears Abbott’s TactiCath Sensor Enabled AF contact force ablation cath
Abbott (NYSE:ABT) said today that it won FDA approval for its TactiCath Sensor Enabled contact force ablation catheter intended for use in treating atrial fibrillation. The newly cleared TactiCath SE is intended to provide precise images of the heart overlaid with real-time electrical activity information, the Chicago-area medtech company said. The catheter also features an ergonomic […]
Circuit error prompts Medtronic to recall 157k dual-chamber pacers
Medtronic (NYSE:MDT) is suspending distribution and selectively recalling approximately 156,957 of its Adapta, Versa and Sensia dual-chamber pacers over circuit error issues that could affect overall device functionality, according to an urgent release from the company. The issue occurs when the devices are programmed to a dual chamber mode with atrial-sensing, the Fridley, Minn.-based company said, […]
FDA clears Verily’s Study Watch for on-demand ECG
Alphabet‘s (NSDQ:GOOGL) life sciences group, Verily, said today that it won 510(k) clearance from the FDA for its Study Watch for its on-demand electrocardiogram feature. In a blog post published today, the head of Verily’s cardiovascular health innovations unit, Dr. Michael McConnell, wrote that the Study Watch indication covers the recording, storage, transfer and display of […]
FDA takes big step toward over-the-counter naloxone
In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment. A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, […]