Press Releases

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

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

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

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

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

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®

Olympus Corp., a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today the launch of the ScopeLocker Air endoscope drying cabinet, offering a new drying option for healthcare facilities. Drying endoscope channels is a critical component of reprocessing. The ScopeLocker Air endoscope drying cabinet, manufactured by Capsa Healthcare and distributed by Olympus Corp., helps facilitate the drying process and is desi

Aesculap, Inc. (Aesculap), an industry leader in sterile processing and operating room solutions, is pleased to announce the extension of its partnership with Ascendco Health, an innovative health tech company, for another ten years. The partnership, which began five years ago, aims to transform perioperative workflows by combining Aesculap's industry-leading expertise in surgical instrumentation and sterile processing with Ascendco Health's proprietary asset management technology.

Medline today announced it has entered into a distribution and supply agreement with TenderHeart Health Outcomes, a Texas-based provider dedicated to providing high-quality medical supplies and innovative patient-centric programs. As part of the agreement, TenderHeart is using the Medline Home Direct™ Program to ship medical supplies directly to TenderHeart's patients' homes; these include enteral feeding, urology, ostomy and wound care supplies, breast pumps, pediatri

Avant Technologies, Inc. and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced the companies are exploring options to integrate the early detection of dementia into Ainnova's proprietary, AI-powered platform technology, Vision AI.  The addition would reinforce the Company's mission of expanding AI-powered early detection and preventative heal