Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
The European Commission launched a new research initiative with $10 million from Horizon Europe, the E.U.’s research and innovation program, to create a cutting-edge decision-making tool to help clinicians and patients select the best lung cancer treatment based on each patient’s specific needs and circumstances. The I3Lung initiative brings together 16 international partners from Germany, Belgium, Denmark, Italy Sweden, Switzerland, the U.S. and Israel.
Cognetivity Neurosciences Ltd. is making progress in promoting its cognitive assessment tool as the brain health equivalent of a blood pressure check, following feedback from clinicians indicating the test could have broad applicability.
Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.
Medtronic plc has entered a strategic collaboration with Cathworks Ltd. to expand the reach of Cathworks’ artificial intelligence (AI) guidance system for coronary artery disease management. Medtronic will invest up to $75 million and immediately begin co-promotion of the Ffrangio system on the U.S., European and Japanese market. As part of a separate agreement, Dublin-headquartered Medtronic will have the option to acquire Cathworks once certain undisclosed milestones are met.
Clinical analytics company Medial Earlysign Ltd. is expanding an existing partnership with Roche Holding AG to commercialize an artificial intelligence (AI) solution for the early detection of lung cancer. The companies originally signed an agreement in September to develop a personalized health solution for early detection of gastric cancer. The goal of the new collaboration is to develop Earlysign’s Lungflag software, which uses machine learning to identify patients at risk of developing lung cancer.
A French public-private consortium of seven med-tech companies, research institutes and specialist cancer hospitals is launching a new project to standardize and improve access to health care data for cancer research. Paris-based Arkhn SAS and Owkin SAS joined forces with INRIA, the French national institute for research in digital science and technology, to launch Oncolab.
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022 Assistive Technology Conference. Envision has updated its AI-based platform and ecosystem with improved optical character recognition (OCR) and better text recognition with contextual intelligence.
Regulatory harmonization of artificial intelligence (AI) and machine learning (ML) is high on the checklist for companies that want to develop these products, but legislatures and regulatory agencies across the globe seem less interested. Koen Cobbaert, senior manager for quality standards and regulation with Royal Philips NV, told BioWorld that there is a race on to be the first market with a full-fledged set of regulations, a fact of life that does little to advance the cause of harmonization.
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
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