New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S. Ourcrowd, an investment platform that simplifies investment by accredited investors and others in startups, early-stage companies and venture funds, led the round. Other participants included a group of family offices and private investors.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.
Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.
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an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms.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.