South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.
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.
Shionogi & Co. Ltd. is partnering with Fronteo Inc. to develop artificial intelligence (AI)-based diagnostic tools to diagnose mental and neurological disorders more accurately.
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.
Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam.
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.
In a post-pandemic world, South Korean molecular diagnostics firm Seegene Inc. is looking to ignite a new paradigm in the diagnostics business. Seoul-based Seegene is rolling out a new strategy of open innovation under its newfound initiative coined the “SG Onesystem,” which pledges to not only accelerate global partnerships for novel diagnostics but also “free the world of all disease.”
