French medical device manufacturer Medicrea International and its American affiliate Medicrea USA have agreed to pay $2 million to settle alleged kickbacks to physicians and other Medicare Open Payments program violations. The company agreed to pay $1 million to the U.S. and participating states to resolve civil whistleblower allegations that the company violated the Anti-Kickback […]
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Boston Scientific’s Acurate Neo performs well in latest trials
Boston Scientific (NYSE:BSX) touted positive results from multiple studies for its Acurate neo2 aortic valve system. Marlborough, Mass.-based Boston Scientific presented results from the investigator-initiated Early neo2 Registry and Ital-neo Registry studies at the EuroPCR 2021 meeting earlier this week, according to a news release. Results from the Early neo2 Registry of 554 patients across […]
Apple debuts software for people with disabilities
Apple yesterday unveiled next-generation software features designed for people with mobility, vision, hearing and cognitive disabilities. Cupertino, Calif.-based Apple’s operating systems are set to undergo software updates later this year that would allow people with limb differences to navigate the Apple Watch using AssistiveTouch, while the iPad will support third-party eye-tracking hardware for easier control and […]
FDA leapfrogs guidance on brain-computer interface devices
The FDA today issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices. Leapfrog guidance allows the agency to share its initial thoughts on emerging technologies that are early in development but appear likely to be of importance to public health, according to a Federal Register notice. The guidance offered […]
Emergo by UL, MedCrypt pair on cybersecurity
Emergo by UL and MedCrypt will jointly offer cybersecurity risk management and mitigation for connected medical devices and systems. Medtech and healthcare technology consulting group Emergo and healthcare cybersecurity developer MedCrypt said this week that they will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting and risk management services to ensure clients understand […]
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Propel […]
Memic may go public through merger with SPAC
Memic Innovative Surgery is reportedly eyeing a move to go public through a merger with SPAC MedTech Acquisition Corp. Bloomberg reported that people with knowledge of the matter say that Memic, which develops Hominis, the first FDA-approved, robotically assisted surgical device for performing transvaginal hysterectomy, is in talks over going public with the SPAC. A […]
Google set to launch its first medical device
Google has unveiled an artificial intelligence-powered tool designed to identify dermatologic issues. In a news release, the technology giant cited billions of yearly Google searches related skin, nail and hair issues as a reason for developing the technology. The company plans to launch the web-based application as a pilot later on this year. Once they […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery, according to […]
CorVent Medical gains CE mark approval for critical care ventilator
CorVent Medical announced that it received CE mark approval for its Respond-19 ventilator and is preparing to launch it in Europe. Santa Clara, Calif.-based CorVent’s Respond-19 ventilator allows hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS). The system received FDA emergency use authorization (EUA) for primary critical care use in December […]
Evolut TAVR just as good as open-heart surgery among younger people, Medtronic says
Medtronic (NYSE:MDT) today touted two-year outcomes for a trial comparing its Evolut TAVR system to open-heart surgery in younger people. Fridley, Minn.-based Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system went up against the gold standard of open-heart surgery in younger, healthier aortic stenosis patients in the trial, which had its results presented as a […]