The U.S. FDA is keen to develop tools for oversight of artificial intelligence (AI) as demonstrated by a batch of research projects designed to inform the review of medical applications of AI. The agency’s concern is that there is a dearth of “robust evaluation methods” for evaluating AI products, thus the need for tools that will allow the agency to clear or approve such products with an assurance that these algorithms are safe and effective for their intended use.

South Korean digital health care firm Seers Technology Co. Ltd. is targeting a ₩22.1 billion (US$16.2 million) IPO on the Korea Exchange, after upping the offering price of its 1.3 million shares to ₩17,000 per share on June 4.

South Korean digital health care firm Seers Technology Co. Ltd. is targeting a ₩22.1 billion (US$16.2 million) IPO on the Korea Exchange, after upping the offering price of its 1.3 million shares to ₩17,000 per share on June 4.

New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.

The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.

Dornier Medtech launched a first-of-its-kind artificial intelligence tool called Urogpt to support patients with kidney stones. Developed in collaboration with leading urologists, Urogpt marks a milestone in the company's commitment to leveraging digital innovation to empower kidney stone sufferers through patient-first solutions. The app provides urology patients with access to on-demand advice and actionable insights that inform and reassure users when navigating the complexities of their condition.

Oncohost Ltd. provided new details on a novel application for its proteomic pattern analysis technology at Biomed Israel last week. While its initial development focused on using a single blood sample to guide selection of first-line immunotherapy for cancer based on likelihood of response, the Prophet platform now also predicts severe adverse immune-related events, Oncohost CEO Ofer Sharon told BioWorld.

Archetype Therapeutics Inc. has discovered compounds for the treatment of early-stage lung adenocarcinoma by screening billions of compounds from the Enamine REAL Space chemical library and other libraries.

Owkin Inc. has in-licensed OKN-4395 (ACT-1002-4391), a highly selective and potent dual inhibitor of prostanoid receptors EP2 and EP4, from Idorsia Ltd.

The European Council (EC) voted to approve the Artificial Intelligence Act (AI Act), a sweeping horizontal legislative product that affects all sectors of the European Union’s (EU) economy. Regulatory attorney Erik Vollebregt told BioWorld that the horizontal nature of the AI Act is still likely to exacerbate some of the problems already seen with the Medical Device Regulation (MDR) in a way that he said will make the EU market less attractive than is already the case.