What You Should Know:
- Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.
- The algorithm will soon be available to users in the U.S. through Fitbit’s new Irregular Heart Rhythm Notifications feature on eligible heart-rate tracking devices.
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FDA Clearance
Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App
What You Should Know:
- Arterys, the world's leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.
- Cardio AI is a comprehensive, cloud-based post-processing solution that leverages AI and deep learning to provide extremely accurate, automated, fast, repeatable analysis of cardiac MRI images.
Cardio AI: AI-Assisted Cardiac MRI
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Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis
What You Should Know:
- Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding in the company to over $20 million, including partnerships with Foxconn, Roche Diagnostics, the Defense Threat Reduction Agency, and others.
- Precision medicine company will use the funding to
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MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform
What You Should Know:
- MediView XR, Inc., raises $9.9M in SAFE financing syndicated by Inside View Investments, LLC, a private investment firm. MediView has raised approximately $14.4MM in total funding to date.
- Investment will support key technology development, commercialization and regulatory submissions.
MediView XR Inc., a Cleveland-based medtech company that leverages augmented reality, remote connectivity and spatial computing data to create revolutionary surgical
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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 technology, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)
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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 access to medical devices (in this case, software as a medical device, or SaMD) by speeding up their
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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 data collected by LINQ II, improving the accuracy of information physicians receive so they can better diagnose and treat abnormal heart
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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
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Bose Launches First FDA-Cleared DTC Hearing Aids
What You Should Know:
- Bose is entering the digital health market launch of Bose SoundControl Hearing Aids – the first FDA-cleared, direct-to-consumer hearing aid.
- Weighing 3 grams each, the new SoundControl™ Hearing Aids are developed for adults with perceived mild to moderate hearing loss. Eight batteries are included in total, and one lasts up to four days when used 14 hours daily. They can be replaced wherever hearing aid batteries are sold and easily changed via a
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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 health monitoring, today announced that it has raised $14M in Series A funding, bringing the total capital raised to
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