Medtronic (NYSE:MDT) is touting new data from its WRAP-IT study demonstrating the cost-effectiveness of its TYRX absorbable antibacterial envelope. Fridley, Minn.-based Medtronic designed its TYRX absorbable antibacterial envelope for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs). Results from the WRAP-It study, published in Circulation: Arrhythmia and Electrophysiology, showcase the cost-effectiveness […]
CoreMap gains $10.5M in Series A round
Burlington, Vt.-based startup CoreMap has secured $10.5 million in a Series A funding round led by Qure Ventures. Founded in 2016, CoreMap is taking aim at atrial fibrillation (AF) with technology designed to map complex arrhythmias inside the heart. The company’s patented system combines an electrode pair design in a high-density array configuration with algorithm-driven […]
Advisory panel to vote on FDA approval of Neovasc Reducer
Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval. The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a […]
Former Corindus CEO Toland joins medtech investment firm
BioStar Capital announced today that former Corindus Vascular Robotics CEO Mark Toland has joined the firm as a partner and EIR. As a partner and entrepreneur in residence (EIR), Toland is slated to help in the discovery, development and nurturing of new startups with high-growth potential. He will also have the flexibility to function in […]
Fitbit wins U.S., EU regulatory approval for ECG app
Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app. San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release. The Fitbit […]
Which TAVR device is the best? It depends, researchers say
Researchers published a paper in the Journal of the American Medical Association citing insufficient evidence regarding the superiority of TAVR devices. Currently, only three TAVR devices are commercially available in the U.S., belonging to Edwards Lifesciences (NYSE:EW), Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX), although several others are being used in clinical trials to evaluate safety and efficacy. Get the full story at our […]
Medtronic TTVR system wins breakthrough device designation
Medtronic (NYSE:MDT) announced that it received FDA approval for an early feasibility study of its Intrepid TTVR system. Fridley, Minn.-based Medtronic’s Intrepid TTVR (transcatheter tricuspid valve replacement) system is designed for patients with severe, symptomatic tricuspid regurgitation, treating a diseased, damaged or malfunctioning valve that allows blood to flow back into the upper right chamber of […]
Bardy Diagnostics names new CEO
Bardy Diagnostics announced that it appointed Kevin Hykes as its new president, CEO and member of its board effective Aug. 31, 2020. Hykes has more than 28 years of experience in the medical device industry, having served as president and CEO of Relievant Medical Systems, Metavention and Cameron Health. Additionally, Hykes held roles as an […]
InspireMD wins FDA approval for carotid stent system study
InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. Get the full story on our sister site, Medical Tubing + […]
Boston Scientific stent gains added Medicare coverage
Boston Scientific (NYSE:BSX) announced today that CMS granted a new technology add-on payment (NTAP) for its Eluvia system. Marlborough, Mass.-based Boston Scientific’s Eluvia drug-eluting vascular stent system received the NTAP as part of the 2021 inpatient prospective payment system (IPPS). The NTAP will be made effective on Oct. 1, 2020, to provide eligible hospitals with incremental […]
CMS rate cuts for Abiomed Impella not as bad as expected
CMS will pay 11% less for the tiny Impella heart pump made by Abiomed (NSDQ:ABMD) during the upcoming federal fiscal year — but the reduction is better than the 24% cut originally proposed. For the federal fiscal year ended Sept. 30, 2021, the rate for uni-ventricular Impella percutaneous insertion will be $71,950, down from the previous […]
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