FDA Clearance

Cardiologs Awarded FDA Clearance for Pediatric Use of Algorithm

What You Should Know: Cardiologs announced today that the FDA has cleared their algorithm to be used for the pediatric population – younger than 18. Their technology can now analyze ECG readings for atrial arrhythmias across all age groups. Cardiologs, a medical technology company committed to transforming cardiac diagnostics using medical-grade artificial intelligence and cloud …

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Biofourmis Earns FDA Breakthrough Device Designation for Digital Therapeutic for Heart Failure

What You Should Know: – Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). – The Breakthrough Devices Program was created to provide patients and providers with timely …

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Medtronic Awarded FDA Clearance for 2 AI Algorithms for Cardiac Monitoring

What You Should Know: – Medtronic announced U.S. Food and Drug Administration (FDA) clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ insertable cardiac monitor (ICM) – and the presentation of AccuRhythm AI validation data this week at Heart Rhythm 2021. – AccuRhythm AI applies artificial intelligence (AI) to heart rhythm event …

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Cognoa Awarded FDA Authorization For AI-Based Autism Diagnosis Aid

What You Should Know: – Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, has been granted FDA authorization to market the company’s first-of-its-kind, AI-based autism diagnosis aid – Canvas Dx. – Canvas Dx is the first diagnosis aid designed to help physicians to diagnose autism spectrum disorder (ASD) in the primary care setting, as well as the first diagnosis aid for ASD authorized for commercialization by …

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Casana Raises $14M to Expand IoT Heart Health Toilet Seat

What You Should Know: – Casana raises $14M in Series A funding to pursue FDA clearance for its an IoT heart health toilet seat that captures clinically relevant measurements, including heart rate, blood pressure, blood oxygenation, and cardiac output. Casana, previously known as Heart Health Intelligence, Inc., a healthcare technology firm that is re-inventing in-home …

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Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

What You Should Know: – Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital therapeutic proven to significantly reduce or eliminate panic attacks and PTSD symptoms by training users to normalize respiratory irregularities. – In 28 days, Freespira can reduce or eliminate panic attacks …

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AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms

What You Should Know: – AliveCor announced they received FDA clearance of new algorithms for use with their personal EKG devices, KardiaMobile and KardiaMobile 6L. These additional determinations will be available via a software upgrade for the Kardia devices in 2021. – The additional FDA-cleared algorithms double the number of heart rhythm disturbances that AliveCor’s …

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FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

What You Should Know: – Scopio Labs announced FDA clearance of its AI-powered X100 microscope and decision support system with Full Field Peripheral Blood Smear (Full Field PBS) application.  – Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans with full-field view of …

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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, …

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Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

What You Should Know: – The National Institutes of Health (NIH) has granted next-generation cardiac AI company Eko an award totaling $2.7 million to support continued collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute – The grant will focus on validating algorithms and help more accurately screen for heart murmurs and valvular heart disease during …

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Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery

What You Should Know: – Digital surgery pioneer Activ Surgical raises $15M in funding led by ARTIS Ventures to accelerate U.S. commercialization and European expansion efforts for its ActiveEdge platform, which enables existing surgical systems, from scopes to robots, to visualize, characterize and track tissue, in real-time beyond today’s human capability.  – ActivSight, is an …

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