The U.S. FDA has issued an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms. There is no guarantee a final guidance will emerge before 2022, however, leaving developers with another year – perhaps longer – of uncertainty as to how to handle change control for their algorithms.

NEW DELHI – India, which has the highest incidence of tuberculosis (TB) in the world and the second highest of COVID-19, is looking to artificial intelligence (AI) to help detect and classify cases of both and lower the cost of diagnosis.

Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.

HONG KONG – A new algorithmic module developed by Rsip Vision Ltd. makes it possible to generate automated expert-level assessment of heart functions, facilitating quick and reliable detection of cardiac illness and heart attacks.

Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.

HONG KONG – A new prototype hand-held device coupled with an artificial intelligence (AI)-powered app could make it possible for women to screen for breast cancer at home cheaply and efficiently. The device, the Blue Box, is the brainchild of Judit Giro? Benet, a 23-year-old junior specialist at the Center for Embedded Cyber-physical Systems at the University of California, Irvine, who is working with her Taiwanese partner Billy Chen to get their Blue Box to market.

Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis.

TORONTO – Waterloo, Ontario-based DarwinAI Corp. and Raleigh, N.C.-based Red Hat Inc.are developing a suite of deep neural networks for COVID-19 detection and risk stratification via chest radiography in cooperation with Boston Children’s Hospital. DarwinAI designed COVID-Net as “explainable” artificial intelligence (AI) that illuminates the inner workings of AI-driven medical technologies and promptly offered it on an open-source platform for the broader hospital community.

The COVID-19 pandemic has been more than just a distraction for the U.S. FDA, which started 2020 with a number of ambitions regarding digital health regulation. Despite having unveiled the Digital Health Center of Excellence to great fanfare, the agency is struggling to wrap up major digital health programs, such as the precertification program for software as a medical device, leaving the FDA with a daunting agenda for digital health in the coming year.

HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.