There’s an ongoing debate regarding the role that consumer health technology, like wearable health devices (i.e., smartwatches), can play in diagnostics, now and in the future. Because this is a relatively new technology, the scope of its potential impact is, at present, only scraping the surface. Even so, smartwatches and their connected health apps are reshaping the healthcare industry. This technology has the ability to not only make personalized healthcare more widely accessible, but its
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FDA Clearance
AI-Enabled Butterfly Network Lung Tool Receives FDA Clearance
What You Should Know: - Today, Butterfly Network announced it received 510(k) clearance from the FDA for a groundbreaking AI-enabled tool named AI-enabled Auto B-line Counter that will help physicians assess adults’ lungs and accelerate providers’ abilities to make informed treatment decisions. Butterfly used data inputs from hundreds of sites across the country to train and develop its AI algorithms, offering potential for a broad and diverse range of age, gender, body mass index, ethnicity,
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TytoCare Receives FDA Clearance for AI-Powered Tyto Insights for Wheeze Detection
- TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US. - The wheeze detection algorithm expands the company’s existing AI-powered Tyto Insights™ smart diagnostic capabilities, filling the quality gaps currently experienced with traditional telehealth and alleviating challenges imposed by the ongoing shortage of healthcare
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Clarius Awarded FDA Clearance for AI Ultrasound Musculoskeletal Imaging App
What You Should Know: - Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, receives 510(k) clearance for its new MSK AI model, which automatically identifies and measures tendons in the foot, ankle, and knee using artificial intelligence (AI). - The new MSK AI model will be available soon with the Clarius L7 HD3 and Clarius L15 HD3 high-frequency, wireless handheld ultrasound scanners. AI Driven Imaging To Improve
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Selux Receives FDA Clearance for its Rapid Antibiotic Susceptibility Test (AST) System
What You Should Know: - Selux Diagnostics has been granted 510(k) clearance from the US FDA for its Next Generation Phenotyping (NGP) System — a rapid antibiotic susceptibility (AST) testing platform able to determine a bacteria’s susceptibility to a specific panel of antimicrobial agents. - In vitro antimicrobial resistance test enables clinical labs to deliver targeted therapeutic results days faster than the current standard of care, clearing the path for personalized antibiotic
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Valencell Unveils Calibration-Free, Cuffless Blood Pressure Monitor
What You Should Know: - Valencell, the company whose optical heart rate technology enabled the ability of wearables to accurately measure cardiovascular vitals during exercise, today announced plans to launch its own branded product line in the digital health sector as it concentrates efforts to bring solutions to market to manage chronic diseases. - The company’s first product candidate being showcased at CES is focused on helping people monitor and manage hypertension by combining
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Dexcom Receives FDA Clearance for G7 Continuous Glucose Monitoring (CGM) System
What You Should Know: - The FDA has cleared Dexcom G7 continuous glucose monitoring (CGM) system in the U.S. for people with all types of diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution. - Cleared as an integrated continuous glucose monitoring (iCGM) system, Dexcom G7 will be part of the most connected CGM ecosystem in the world, with real-time connectivity that can drive integrated insulin delivery systems, connect
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Eyenuk Raises $26M for AI-Powered Eye Screening & Predictive Biomarkers
What You Should Know: - Eyenuk, Inc., a global artificial intelligence (AI) digital health company and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, today announced it has secured $26 million in a Series A financing round, bringing the Company’s total funding to over $43 million. - The capital raise was led by AXA IM Alts and was joined by new and existing investors including T&W Medical A/S, A&C Foelsgaard Alternativer ApS, Kendall
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Optellum Raises $14M for AI-Enabled Lung Cancer Diagnosis
What You Should Know: - Optellum, an Oxford-based digital health company that provides a breakthrough AI platform to diagnose and treat early-stage lung cancer raises $14M in Series A funding led by Mercia, with additional investors Intuitive Ventures and Black Opal Ventures. Existing investors, including St John's College in the University of Oxford, IQ Capital, and the family office of Sir Martin & Lady Audrey Wood, also participated in this round. - The investment will enable
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Assisted Polyp Detection Device Receives FDA Clearance
What You Should Know: - Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced recently that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. - The device was evaluated in the largest U.S.-based multicenter clinical study for a
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