Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions.
Truscreen Group Ltd. completed its largest clinical trial to date that showed its cervical cancer screening device surpassed liquid-based cytology (LBC) screening in 15,651 women across 64 hospitals in nine provinces in China over three years.
Pangea Biomed Ltd. picked up $7 million in seed financing to fast-track development of its multicancer, multitherapy response predictor Enlight. The platform combines machine learning and RNA sequencing to map tumor molecular signatures and predict how different cancer types will respond to oncology drugs. Pangea said instead of using transcriptomic data, it is utilizing ‘unsupervised’ AI techniques that harvest information about gene interactions.
Valuations in the med-tech space lately call into question the old medical adage: “If you hear hoofbeats, think horses.” These days, you would be wise to consider unicorns in the differential diagnosis. Two new companies achieved the formerly rare status just this week. Viz.ai Inc.’s closing today of a $100 million series D financing propelled it into the stratosphere with a $1.2 billion valuation, joining Bostongene LLC which completed its own $150 million round Wednesday.
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
With FDA clearance of its Endoscreener that uses artificial intelligence (AI) to detect polyps during coloscopy procedures, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools.
Biobeat Technologies Ltd. reported its remote patient monitoring system received FDA clearance to monitor respiratory rate and body temperature. The wireless chest and wrist monitoring device is already cleared for cuffless blood pressure monitoring, blood oxygen saturation and pulse rate. The artificial intelligence platform utilizes a photoplethysmography-based sensor at the surface of the skin that measures volumetric variations of blood circulation.
Much of the question of FDA regulation of artificial intelligence (AI) and machine learning (ML) is seen as revolving around changes to the statute, but that does not mean the FDA and other agencies are in wait-and-see mode. Representatives of both the FDA and Health Canada said on a March 22 webinar that guidances related to these algorithms will be posted later this year, thus opening the door to a more predictable premarket path for these products.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
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