Nano-x Imaging Ltd.’s (Nanox) subsidiary Nanox.AI has received the FDA’s 510(k) clearance for Healthost, an artificial intelligence (AI) software device providing qualitative and quantitative analysis of the spine from CT scans.
Computational disease modeling company Cytoreason Ltd. is expanding its reach into Asia with a recent partnership with South Korean big data company Helixrus Inc., which is focused on biological big data and multiomics. The alliance will focus on leveraging Helixrus’ deep knowledge of the South Korean pharmaceutical market, and extensive network of relationships in Asian markets, to highlight Cytoreason’s capabilities in prioritizing new targets, finding biomarkers, profiling combinations, stratifying patients and other use cases within the drug lifecycle.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
Canada’s federally-funded Digital Technology Supercluster is joining with industry to invest CA$17.8 million (US$13.9 million) in an artificial intelligence (AI)-powered technologies program to advance personalized treatment for patients with cancer.
Yes, getting FDA 510(k) clearance for your medical device is something to cheer about. But consider Arterys Inc. It just reported its eighth FDA clearance, this time for a next generation, deep learning cardiac analytics platform. The Cardio AI’s purpose, Arterys CEO John Axerio-Cilies told BioWorld, is to leverage artificial intelligence (AI) and deep learning for analysis of cardiac MRI images that is faster, more accurate and repeatable than ultrasound and other imaging modalities.
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.
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