Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.

ARC (Accelerate, Redesign, Collaborate), the innovation arm of Israel’s Sheba Medical Center is looking to use the principles of gaming and simulation to create smarter, more scalable solutions that will benefit both patients and providers.

A team of U.S. and South Korean researchers have developed an AI model called MSI-SEER that can not only predict microsatellite instability-high (MSI-H) tumors based on tissue slides, but also flag “what it does not know.” “Have you ever asked ChatGPT anything, and the response was, ‘I don’t know?’” Cheong Jae-ho asked during an interview with BioWorld. “Probably not, and that is the problem with AI now.”

Pharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model. Each of the partners is contributing data from several thousand experimentally determined protein:ligand interactions, creating one of the most diverse datasets and the richest chemistry assembled to date for model training.

AI seems to suggest that a world of problems with health care spending may become more manageable, but Stephen Bittinger, a shareholder in the D.C. office of the law firm of Polsinelli PC told BioWorld that all the headaches surrounding validation of these algorithms suggests a need for an independent AI validation institute.

China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.

A new generative AI model trained on UK Biobank data can simultaneously forecast the risks and timing of developing over 1,000 different diseases a decade into the future. The developers applied similar algorithmic concepts to those used to develop large language models like ChatGPT and Gemini to build the model, using medical records from 402,799 participants in UK Biobank.

China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.

The first phase of the EU’s Data Act is now officially in place, although member state enforcement of the Act might be spotty. This is because several nations, including Germany, have yet to finalize implementing regulations for the Data Act, a problem these nations will have to fix as the secondary and tertiary compliance dates arrive in August 2026 and August 2027.

Companies developing AI-based health care solutions need to ensure they have quality data, a solution that can easily integrate into clinical workflow systems and teams with evolving skills, to attract investment, delegates heard at the LSI Europe ’25 conference in London.