Press Releases
CIVIE, a leading healthcare technology and services company, today announces the official launch of RadPod, an AI-driven, on-demand radiology platform designed to transform how, when and where radiologists work. RadPod was developed to align the interests of radiologists, hospital systems and the latest in healthcare technology to ensure the practice of radiology is a win-win-win. Powered by CIVIE’s cutting-edge AI technology, radiologists can read and interpret medical imagin
Read more...CRH Medical Corporation (“CRH”), a leading provider of products and services for gastrointestinal (GI) providers and a wholly owned subsidiary of WELL Health Technologies Corp. (“WELL”), has announced a strategic partnership with WovenX Health (“WovenX”), a leader in integrated virtual specialty care. Together, they aim to deliver integrated, next-generation GI practice solutions designed to resolve persistent challenges surrounding patient access and opera
Read more...Microbot Medical Inc. developer of the innovative LIBERTY Endovascular Robotic System, today announced the continued expansion of its commercial team in preparation for the anticipated U.S. launch of the LIBERTY System, which is projected during the third quarter of 2025. The Company remains actively engaged with the U.S. Food and Drug Administration (FDA), with a 510(k) decision now expected during the third quarter of this year. This updated FDA decision timeline remains within the FDA&rsqu
Read more...Foldax® Inc., a leader in heart valve innovation, today announced that the Indian Central Drugs Standard Control Organization (CDSCO) approved its TRIA™ Mitral Valve. Dolphin Life Science India LLP will locally manufacture the TRIA Mitral Valve in India. Traditional valves made from animal tissue are prone to calcification and degradation, limiting their durability and often leading to repeat surgeries, especially for younger patients. Mechanical valves, while durable, are
Read more...HeartSciences Inc, an artificial intelligence (“AI”) powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Device designation for its Aortic Stenosis (“AS”) ECG algorithm. Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and lead
Read more...4 June 2025
Corify Care, an AI-driven medical technology company specializing in global cardiac mapping and real-time precision guidance for the treatment of cardiac arrhythmias, announced today it has entered into a know-how agreement with Mayo Clinic. Nearly 60 million people worldwide are affected by atrial fibrillation, yet treatment outcomes for complex cases remain ineffective. More than 50 percent of ablation procedures for complex arrhythmia fail, in many cases because clinicians are un
Read more...4 June 2025
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical aver
Read more...Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era of precision medicine in breast cancer. Each year, mo
Read more...31 May 2025
AIxMed, an innovator in AI diagnostics for urine cytology and Lumea, a leading provider of primary clinical digital pathology solutions, today announced a new partnership. This collaboration will integrate AIxMed's specialized AI technology into Lumea's FDA-cleared digital pathology platform, broadening the advanced diagnostic tools available to the urology market. AIxMed's solution AIxURO is designed to assist in the analysis of non-invasive urine cytology specimens, ai
Read more...30 May 2025
Iradimed Corporation a global leader in innovative medical devices for MRI environments, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System. This advanced, MRI-compatible infusion pump extends Iradimed’s unique position as the world’s only supplier of non-magnetic MRI infusion pump devices, established with our first-generation device in 2005. The MRidium®
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