Cognito Therapeutics Inc. has revealed that its lead product has received breakthrough device designation from the U.S. FDA for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease. The offering is a noninvasive neurostimulation device using gamma frequency technology and is the initial candidate in the company’s pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomerica, Cognito Therapeutics, Cytosorbents, Jud Care, Medskin Solutions Dr. Suwelack, Microvention, Ortho, Quanterix, Therapixel.
In recent years, Israel has proven to be a hot spot for med-tech innovation. The country boasts more than 1,500 companies in the health care and life sciences sectors, roughly 70% in medical devices and digital health. More than a hundred new companies focused on medical technology launch each year.
Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.
HONG KONG – A new algorithmic module developed by Rsip Vision Ltd. makes it possible to generate automated expert-level assessment of heart functions, facilitating quick and reliable detection of cardiac illness and heart attacks.
Telehealth has been topical in the U.S. for several years now, but the COVID-19 pandemic lent new urgency to the question of Medicare coverage. However, there are a number of related enforcement issues that could dampen adoption and increase the legal risk for both health care professionals and developers of telehealth-related products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Visionquest, Zetroz Systems.
Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.
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