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Home » Topics » Diagnostics » Artificial intelligence

Artificial intelligence
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Cardio AI software

Arterys wins eighth FDA clearance for enhanced deep learning MRI

April 26, 2022
By David Godkin
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.
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FDA advises on intended use of software used for patients with intracranial occlusions

April 13, 2022
By Mark McCarty
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.
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Voqx digital stethoscope

FDA clears AI-infrasound smart stethoscope from Sanolla

April 12, 2022
By Catherine Longworth
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.
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Female health professional holding Truscreen device

Truscreen’s AI cervical cancer screening tool showing promise for primary screening

April 8, 2022
By Tamra Sami
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.
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Pangea group photo

Pangea Biomed reels in $7M for pan-cancer response predictor

April 8, 2022
By Catherine Longworth
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.
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Businessman riding unicorn atop arrows in the clouds

Viz.ai’s valuation surges to $1.2B with $100M series D

April 7, 2022
By Annette Boyle
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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Image from GI Genius intelligent endoscopy module

Medtronic’s GI Genius in study for detecting adenomas during colonoscopy

April 4, 2022
By Nuala Moran
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.
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AI detection of colorectal cancer in endoscopy, histopathology

Wision AI expands US screening offerings to combat colorectal cancer

April 1, 2022
By Tamra Sami
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.
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Biobeat smartwatch and patch

Biobeat adds new FDA clearances to remote monitoring device

March 29, 2022
By Catherine Longworth
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.
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Artificial intelligence and digital health icons

2022 to be the year of draft guidances for AI and machine learning

March 22, 2022
By Mark McCarty
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.
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