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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FDA Clearance
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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4 Predictions for Diabetes Management and Technology in 2021
The COVID-19 pandemic continues to put an unprecedented amount of strain on the entire healthcare sector, and the industry has responded by accelerating the ways innovation is developed and adopted. Health leaders have faced a generational challenge and the result has been the rapid deployment of technology to address dire patient needs. Health systems, physicians, and frontline staff pulled together in remarkable fashion to implement these emerging technologies that enhance the ways patients
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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 and PTSD symptoms from home with just a tablet, sensor, and custom app.
There’s no medicine with possible side effects and no need
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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 Kardia devices can detect,
broadening the number of patients who are able to use their remote
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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 the monolayer and feathered edge at 100X oil immersion resolution level.
- The global market for
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