The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.
Surgical robotics company Virtual Incision Corp., of Lincoln, Neb., has raised $20 million in a series B+ financing led by returning investor Bluestem Capital. The funds are earmarked for clinical and regulatory programs aimed at commercializing the company’s MIRA (miniaturized in vivo robotic assistant) surgical robotic platform.
Caesarea, Israel-based Icecure Medical Ltd. has won the FDA’s nod for additional indications for its cryoablation technology, paving the way for use in kidney, liver, ear, nose and throat and new neurology indications. The agency also cleared Icecure’s new Multisense system.
Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see.
Neovasc Inc., of Richmond, British Columbia, has submitted a premarket approval application to the U.S. FDA for its Neovasc Reducer. The minimally invasive stent, which was granted breakthrough status in October 2018, is used to treat refractory angina.
Drug diversion in hospitals is a serious concern, facilitated in part by inadequate security controls that allow unauthorized staff to access the pharmacy stock. To help thwart this problem and improve medication management, Taipei, Taiwan-based Cyberlink Corp. and Imedtac Co. Ltd. are teaming up to bring facial recognition technology to the hospital medicine cabinet.
Drug diversion in hospitals is a serious concern, facilitated in part by inadequate security controls that allow unauthorized staff to access the pharmacy stock. To help thwart this problem and improve medication management, Taipei, Taiwan-based Cyberlink Corp. and Imedtac Co. Ltd. are teaming up to bring facial recognition technology to the hospital medicine cabinet.
Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.
Health care-associated infections (HAI) pose a constant challenge for hospitals and health systems, resulting in increased morbidity and mortality and billions in costs each year. According to the Centers for Disease Control and Prevention, about 1 in 31 patients has at least one HAI at any given time. In 2016, the U.S. Department of Health and Human Services set a 2020 goal of reducing HAIs by 50% below a 2015 baseline. To that end, Biotia Inc. plans to launch an artificial intelligence (AI)-enabled test to detect harmful bugs and antimicrobial resistance (AMR) early in the new year.
