- 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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FDA Clearance
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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Eko Lands $2.7M NIH Grant to Train Pulmonary Hypertension AI
What You Should Know:
- Eko, a digital health company applying machine learning in the fight against heart and lung disease, today announced that it was awarded a $2.7M Small Business Innovation Research (SBIR) Direct Phase II grant by the National Institutes of Health’s (NIH) Department of Health and Human Services (HHS).
- The grant will fund the development of a machine learning algorithm that detects and stratifies pulmonary hypertension (PH) using phonocardiogram (PCG) and
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RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage
What You Should Know:
- RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, the newest addition to the RapidAI platform.
- The tool empowers physicians to quickly assess the severity of injury in patients with acute neuro conditions such as traumatic brain injury and brain hemorrhages – allowing for better and faster patient care decisions.
AI Powered
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