The world of artificial intelligence (AI) regulation is still in its infancy, but a number of agencies are nonetheless keen on harmonization for at least some of this policymaking task. The FDA announced recently that it has joined with Health Canada and the U.K. Medicines and Healthcare Products Regulatory Agency to develop a series of 10 guiding principles for good machine learning practices (GMLP), thus answering one of the key questions facing developers of these algorithms.

Digital musculoskeletal health company Hinge Health Inc. kicked its fundraising into high gear this year, reporting $400 million in a series E round and $200 million in a secondary investment today. It closed a $300 million series D just last January. The San Francisco-based company has now raised more than $1 billion and achieved a valuation in excess of $6.2 billion. Returning investors Tiger Global and Coatue Management led the series E, while new investors Alkeon and Whale Rock took a stake in the company with their $200 million. Investors in the series D and previous rounds included Atomico, Insight Partners, Quadrille, 11.2 Capital, Lead Edge Capital, Bessemer Venture Partners and Heuristic Capital.

PERTH, Australia – Singular Health Group Ltd. was awarded AU$50,000 (US$37,000) in funding from Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) Kick-Start program to undertake a research project to develop artificial intelligence (AI)-based tools to automatically design patient-specific cranial implants. The AI will be integrated into Singular Health’s surgical planning software for editing before the cranial implants are 3D printed.

Alivecor Inc. is partnering with blockchain technology company Solve.Care to connect users of its Kardiamobile device to physicians through a telehealth network. Tallinn, Estonia-based Solve.Care’s blockchain platform, the Global Telehealth Exchange (GTHE), is an open global cross-border telehealth network currently available in 27 countries. Alivecor’s Kardiamobile 6L device is the first and only six-lead personal ECG cleared by the FDA. Through the partnership, Kardiamobile devices will be integrated with GTHE where physicians will be able to access a user’s electrocardiogram (ECG) reading upon their consent through teleconsultations.

The FDA’s device center has posted its annual fiscal year guidance agenda, and there are several carry-over items from fiscal 2021. The most conspicuous element of the FY 2022 agenda may be that a draft guidance for change control for artificial intelligence (AI) algorithms rates an entry on the B list rather than the A list, suggesting that the draft is not likely to emerge any time in the next 12 months.

Precision cancer care company Simbiosys Inc. has raised $15 million to accelerate development of its Tumor Scope software platform for management of solid tumors. The application enables oncologists to virtualize cancer tumors and simulate a patient’s response to specific drug therapies by combining artificial intelligence with biophysical simulations. The technology models the impact of drug delivery, drug sensitivity, metabolism and spatial heterogeneity and provides data that can be used to inform individual treatment plans.

TORONTO – Pathway Medical Inc. has raised C$1.6 million (US$1.3 million) in an oversubscribed funding round to expand its evidence-based clinical decision support platform and deliver an enterprise version of its point-of-care technology. The current mobile app uses natural language processing and machine learning to give doctors evidence-based answers to questions on patient diagnosis and treatment.

With the support of Singapore’s Economic Development Board (EDB), Medtronic plc has launched the Medtronic Open Innovation Platform (OIP) in Singapore to develop med-tech and digital health solutions for Asia Pacific. The company will invest up to $50 million for this venture.

The parent company of digital health unicorn Everlywell Inc. is expanding its portfolio of women’s health products through the acquisition of Charleston, S.C.-based startup Natalist Inc. The purchase marks Everly Health’s third acquisition of the year following agreements to buy national clinician network PWN Health and home lab testing company Home Access Health Corp. Financial terms of all deals were not disclosed. Headquartered in Austin, Texas, Everly Health will add Natalist’s suite of reproductive products to its existing tests for menopause, fertility hormones and sexual health.