Benchsci (Scinapsis Analytics Inc.), has announced a CAD$95 million (US$70 million) series D funding round. The funds will be used to expand the company’s artificial intelligence (AI) drug discovery platform, Ascend by Benchsci, which enables scientists to discover biological connections, reduce trial and error experimentation, and uncover risks early.

The EU’s Artificial Intelligence (AI) Act is still in the thick of the legislative process, which seems likely to ladle even more regulatory liabilities onto AI software used for medical purposes. Bodo Wiegand, senior advisory at Viopsy, told attendees at a May 18 webinar that between the promise of yet more regulation along with existing coverage and reimbursement hurdles in the EU, developers of medical software are considering whether they should steer clear of developments that qualify as AI simply because of the extraordinary time and expense associated with generating revenues for these projects.

Integrated Biosciences Inc., an early-stage startup that is combining synthetic biology and machine learning in the hunt for drugs that tackle cell senescence, has demonstrated its capabilities in a newly published study in Nature Aging on May 4, 2023, which employed artificial intelligence (AI) to identify three novel compounds that are highly selective for Bcl-2 and that exhibit favorable medicinal chemistry profiles.

The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is a groundbreaking guidance that was enabled by legislation that allows the filing of PCCPs with all device types, not just software as a medical device (SaMD). However, a member of the FDA team acknowledged recently that this new approach to device change management could require that the agency revisit existing guidances such as a guidance for when to file a new regulatory submission for 510(k) devices, thus heralding a series of guidance revisions that may take several years to unwind.

Developers of artificial intelligence (AI) and machine learning (ML) algorithms have found themselves returning repeatedly to the U.S. FDA for seemingly modest updates to their products, a problem that may soon be relieved by an FDA draft guidance on predetermined change control for AI and ML. However, Brad Thompson of Epstein, Becker & Green, P.C., told BioWorld that the terms of the draft “hugely increases the burden on developers to plan ahead” in order to obtain that postmarket relief from repeated 510(k) filings, a concession that device manufacturers and software developers may be more than willing to make.