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 The most conspicuous element of the FY 2022 agenda may be that a draft guidance for change control for artificial intelligence (AI) algorithms rates an entry on the B list rather than the A list, suggesting that the draft is not likely to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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter, Biomérieux, Genentech, Naviswiss, Xtrava Health.
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.
X-trodes Ltd. has raised $4.5 million to develop its portfolio of wearable smart technologies that measure and analyze electrophysiological signals. Tel Aviv-based X-trodes is developing two products – a wireless system “Smart Skin” for sleep monitoring and a wearable system to prevent muscle injuries and accelerate recovery. The core technology is based on an intellectual property (IP) developed in the nanotechnology laboratory of Tel Aviv University.
The question of bias in artificial intelligence (AI) algorithms is generally thought to be overcome by ensuring that the data set used to train the algorithm is representative of the population at large. However, Naomi Aaronson, executive director of clinical evaluation at the Blue Cross Blue Shield Association, said its not that simple because demographic data can combine in unpredictable ways and thus “the only real understanding of whether it works is in the clinical validation” of the algorithm in various settings.
PARIS – Teams from the Pitié-Salpêtrière hospital, the Institute for Research in Development, Sorbonne University and the National Institute of Health and Medical Research are proposing a new technique that uses artificial intelligence (AI) to identify the risk of developing a type of cardiac arrhythmia called Torsades de pointes (TdP) associated with taking certain drugs.