There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.

LONDON – Health data specialist Sensyne Health plc is opening up broader access to its U.S./U.K. patient information system with the launch of a subscription service giving accredited users the ability to interrogate more than 2 million longitudinal electronic health records. At an annual cost of £25,000 (US$34,602) per head, the company will provide “industrial scale” access to anonymized hospital records “to the smallest company or to a single researcher working in academe,” through the new Sensight service, said Paul Drayson, CEO.

The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus increasing the caregivers’ workload. The psychological impact on the patient is also increased, for example when their sleep is disturbed.

China’s Personal Information Protection Law (PIPL) will take effect on Nov. 1, 2021, making it harder for tech firms, including health care companies, to access and use consumers’ personal information. The PIPL was officially passed by the National People’s Congress on Aug. 20.

Stryker Corp. has made its second acquisition of the year, picking up Gauss Surgical Inc. – the developer of an artificial intelligence (AI) platform for real-time monitoring of blood loss during surgery. Financial terms of the deal were not disclosed. Kalamazoo, Mich.-based Stryker’s shares (NASDAQ:SYK) were trading 5% higher following the acquisition. Menlo Park, Calif.-based Gauss Surgical’s Triton AI technology aims to fill a void in maternal health by enabling early detection of hemorrhage.

Centaur Diagnostics Inc. herded up interest in its gamified system for labeling medical data for use in artificial intelligence (AI) applications. The Boston-based company raised $12 million in a series A round that will help Centaur build out its crowdsourced system for labeling medical images, videos, text and audio recordings. The round brings the company’s funds raised to date to $15 million. Matrix Partners led the charge along with Accel Partners, Global Founders Capital, Susa Ventures, and Y Combinator.

The question of whether an artificial intelligence (AI) algorithm can be an inventor has been making the rounds in the past couple of years, and the question came up again in the U.S. District Court for the Eastern District of Virginia. Stephen Thaler, who developed the Device for the Autonomous Bootstrapping of Unified Sentience (DABUS) algorithm that has been credited with two inventions, failed to persuade the court that an algorithm qualifies as an “individual,” and thus patents must still be assigned to humans, at least where the U.S. Patent and Trademark Office is concerned.

TORONTO – Neupath Health Inc. and Cynergi Health Partners have signed a memorandum of understanding that could see Cynergi’s virtual reality (VR) software combined with Neupath’s remote pain management platform. The platform is expected to benefit from the therapeutic potential of Austin, Texas-based Cynergi’s Rilaxta VRx to lower patient anxiety and perception of pain as they walk through restful, VR-created landscapes. “We don’t see another group taking a similar, holistic approach to pain management that we are,” Neupath CEO Grant Connelly told BioWorld.

Health-tech startup Doctor Anywhere Ltd. (DA) has raised $88 million in series C fundraising, as the telehealth sector continues to be attractive for investors. The round is one of the largest private investments ever raised by a Southeast Asian digital health company and was led by growth equity investor Asia Partners. Novo Holdings, Philips, OSK-SBI Venture Partners, EDBI, Square Peg, IHH Healthcare, Kamet Capital and Pavilion Capital also participated.