What You Should Know:
- RapidAI has received FDA clearance for Rapid SDH, its AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma.
- The need for the RapidAI solution is urgent, with SDH cases in US patients expected to increase by nearly 80% before 2040.
AI Module for Detection of Hemispheric Subdural Hematomas
Rapid SDH leverages AI to help neurocritical care teams identify suspected hemispheric subdural hemorrhage
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FDA clearance 510k
Welldoc Awarded FDA 510(k) Clearance for Diabetes Platform
What You Should Know:
Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®.This clearance immediately follows Welldoc’s 10th 510K clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.
A Continuous Glucose Monitoring (CGM) Informed Bolus Insulin Dose
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Viz.ai Awarded 510(k) Clearance for AI-Powered Cerebral Aneurysm Detection Solution
What You Should Know:
- Viz.ai, a San Francisco-based provider of AI-powered intelligent care coordination for stroke, has received FDA 510(k) clearance for Viz ANEURYSM (formerly Viz ANX), the first and only AI-powered cerebral aneurysm detection solution designed to facilitate population screening and enhanced care management.
- The new algorithm uses AI to detect suspected cerebral aneurysms, enabling hospital systems
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Biotricity Awarded FDA 510(k) Clearance for Cardiac Monitoring Device
What You Should Know:
- Biotricity, Inc. (NASDAQ:BTCY), a medical diagnostic and consumer healthcare technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biotres Cardiac Monitoring Device, a three-lead device for ECG and arrhythmia monitoring that is intended for lower-risk patients.
- Most remote cardiac monitors are passive — they don’t record ECG and other cardiac data in real-time — and lack cross-compatibility
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RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization
What You Should Know:
- RADLogics today announced that it has secured
510(k) clearance from the FDA for the company’s novel AI-Powered chest X-ray pneumothorax application,
which identifies and prioritizes chest X-ray scans that appear
to contain a pneumothorax, a collapsed lung, for urgent radiologist review.
- RADLogics’ FDA cleared CT and X-ray solutions
– including this application – are
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Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation
What You Should Know:
- Caption Health AI is awarded FDA 510(k) clearance for
its innovative point-of-care ejection fraction evaluation.
- Latest AI ultrasound tool makes it even easier to
automatically assess ejection fraction, a key indicator of cardiac function, at
the bedside--including on the front lines of the COVID-19 pandemic.
Caption Health, a Brisbane,
CA-based leader in medical AI technology, today announced it has received FDA
510(k) clearance for an updated version of
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Zebra Medical Vision Secures 5th FDA Clearance for Vertebral Compression Fractures AI Solution
What You Should Know:
- Israeli deep-learning medical imaging analytics startup Zebra-Med secures its fifth FDA clearance vertebral compression fractures AI solution for availability in the U.S.
- The AI solution will help health providers close the COVID-19-induced care gaps by identifying more patients at risk of osteoporosis, also known as the “silent killer,” costing over $52B in the U.S. alone.
- Zebra-Med is one of the first companies in the industry to provide an AI
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FDA Clears AI-Powered EchoGo Core for Early Detection of Cardiovascular Disease
- Ultromics has just become one of the first companies to have 510(k) FDA clearance for an AI medical device. - EchoGo will now be available for clinicians in the UK and US to use to help them identify cardiovascular disease earlier. - EchoGo automates cardiac measurements and is the first AI application to measure cardiac strain, improving patient care and outcomes.Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography has
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Biofourmis Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring
- Biofourmis received 510(k) clearance from the FDA for its Analytics Engine as a medical device for ambulatory physiological monitoring.- Milestone approval establishes an AI-powered solution as the foundation for future disease-specific predictive management tools from Biofourmis.- This FDA approval is the second market authorization for Biofourmis, having earned the agency's approval in May 2019 for its Biovitals RhythmAnalytics platform.Boston-based Biofourmis has received 510(K) clearance
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FDA Clears GE Healthcare’s AI Algorithms Embedded on Mobile X-Ray Device
- GE Healthcare awarded Food and Drug Administration’s 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device.
- Algorithms help radiologists prioritize critical cases with a suspected pneumothorax – a type of collapsed lung – by immediately flagging critical cases to radiologists for triage, which could drastically cut the average review time from up to eight hours.
- Critical Care Suite offers
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