Crescom Co. Ltd., of Seongnam-si, Gyeonggi-do, gained domestic approval for its AI-powered software to grade knee osteoarthritis, dubbed MediAI-OA, while launching a new AI-mobile platform, Onzaram, to help manage child growth care.
The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision.
Surgeon, CEO and founder of Hutom Corp., Woo Jin Hyung, is working to level the playing field in the operating room with artificial intelligence (AI) and big data, leveraging digital technology to optimize surgical outcomes.
Despite a slowdown in the fourth quarter (Q4), med-tech deals concluded the year with the highest deal-value total in BioWorld MedTech’s records. In 2023, a total of $10.63 billion was raised from deals, a 33% increase over the $7.99 billion deal total in 2022. Meanwhile, annual M&A value dropped 58%, from $153.09 billion in 2022 to $64.8 billion in 2023.
The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.
Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
The European Union (EU) is steadily making progress on the Artificial Intelligence Act (AI Act), landmark legislation that will affect AI not just for medical uses, but for all uses across the EU economy.
Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said.
Kakao Healthcare Corp. launched an artificial intelligence (AI)-powered mobile application called PASTA on Feb. 1 for continuous glucose monitoring (CGM)-based diabetes care. PASTA pairs with two types of CGM sensors, either from Seoul-based I-sens Inc.’s Caresens Air or San Diego-based Dexcom Inc.’s G7 system.
To date, developers of digital health technologies have had little luck with coverage and reimbursement, but the picture is slowly improving. The U.K.’s National Institute for Health and Care Excellence (NICE) has endorsed two artificial intelligence (AI) algorithms for diagnosis of stroke, although this is limited to an evidence generation framework that puts the sponsors on the hook for generating the data that will allow unlimited use in the U.K.’s trusts.