The U.S. Dept. of Health and Human Services’ Office of the Inspector General recently published a report claiming that the Centers for Medicare and Medicaid Services overpaid medical device suppliers by $34 million. The money went to suppliers of prosthetics, orthotics and other durable medical equipment between 2015 and 2017, according to the report. The […]
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Early stage AED dev Revive Solutions raises $3m
Early stage medical device developer Revive Solutions said this week it raised $3.4 million in a seed financing round to help support the development of its next-gen automated external defibrillator technology. The round was led by newly invested Greenbox Venture Partners and joined by Rock Health, HealthTech Capital, Hippocrates VC and other medical device execs […]
Edwards prioritizes TAVR, TMTT tech in investor day presentation
Edwards Lifesciences (NYSE:EW) today released its strategies for longer-term growth, updated on its technology pipeline and released preliminary financial guidance for the coming fiscal year in its investor day presentation. Edwards lead with news about its transcatheter aortic valve replacement technologies, saying it expects that TAVR opportunity will reach approximately $7 billion by 2024, and that […]
Alimera Sciences wins Health Canada nod for diabetic macular edema implant
Alimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema. The Iluvien device is a sustained release implant that delivers fluocinolone acetonide and is indicated to treat diabetic macular edema in people who have been previously given corticosteroids and did not have a clinically […]
Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3. Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor […]
Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy. The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer. Get the full story at our sister site, Drug Delivery Business News.
Report: Medtech R&D looking to diversification, non-traditional partners to handle hurdles in innovation
Portfolio diversification, improving time to market and the use of real-world evidence are top priorities amongst R&D leaders at medtech companies, according to data from a new survey. Investigators in the survey, performed by Deloitte and AdvMed, were looking to explore challenges R&D leaders face in medtech and how they are responding to shifts throughout […]
Gingrich stumps for medical device tax repeal
Former U.S. House Speaker Newt Gingrich this week published an editorial with StatNews urging members of Congress to repeal the medical device tax. In the opinion piece, Gingrich calls the tax “misguided” and “job-killing” and suggested that the 2.3% tax, which was levied on medical devices as part of the Affordable Care Act in 2010, […]
Early stage neural device dev Tulavi Therapeutics raises $3m
Early stage medical device developer Tulavi Therapeutics has raised approximately $3 million in a new round of equity financing, according to recently posted SEC filings. Tulavi Therapeutics is developing a medical device-based therapy intended to prevent or treat aberrant neural reflex arcs in peripheral and visceral disease. The technology is intended for use through both […]
Notal Vision snags breakthrough designation for home OCT system
Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device. Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home […]
Inspire Medical offers another 1.5 million shares following April IPO
Inspire Medical Systems (NYSE: INSP) is offering 1.5 million shares of common stock for sale to the public, and its stockholders are selling 1 million additional shares of the stock, according to a regulatory filing. The company hopes to make $66.8 million on the sale. Maple Grove, Minn.-based Inspire, which spun out from Medtronic (NYSE:MDT) in 2007, makes devices […]