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| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
AppliedVR Awarded FDA Approval for VR Therapeutic for Lower Back Pain
What You Should Know:
- AppliedVR, an L.A.-based advancing the next generation of immersive therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo approval for its flagship immersive therapeutic, EaseVRx, to treat chronic low back pain, which previously received breakthrough device designation in 2020. The news also comes on the heels of AppliedVR announcing its $36M series B funding round, bringing its total funding to $71M.
- Following
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Heartbeat Health, Withings Partner on New FDA Cleared ECG Smartwatch
What You Should Know:
- Heartbeat Health, a healthcare technology company working to deliver effective, efficient, and engaging heart care, announced that it has partnered with Withings, as they launch their ECG-enabled hybrid ScanWatch in the U.S. on November 9.
- The Withings and Heartbeat integration is a game-changing development in the cardiovascular space - as Atrial Fibrillation, a form of irregular heart rhythm, is significantly underdiagnosed and, in some cases, can be an
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FDA Selects Aetion Evidence Platform to Assess In-Patient COVID-19 Treatments
What You Should Know:
- Aetion, a NYC-based leading real-world evidence (RWE) company, announced that the U.S. Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD.
- This project is designed to demonstrate how using a platform-based approach
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FDA Clears World’s First and Only Smart Knee Implant
What You Should Know:
- Zimmer Biomet Holdings, a global medical technology leader, and Canary Medical, a medical data company, announced U.S. Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ®, the world's first and only smart knee cleared by the FDA for total knee replacement surgery.
- Persona IQ® combines Zimmer Biomet’s proven and trusted knee implant, Persona® The Personalized Knee®, with Canary Medical’s
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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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AMA Assigns CPT Code for FDA-Cleared Solution to Treat Amblyopia (Lazy Eye)
What You Should Know:
- RevitalVision today announced that a new CPT reimbursement code for its solution means millions of U.S. adults with amblyopia can now receive the therapeutic vision training they have needed for years. This software is FDA-cleared and clinically proven to improve vision in adult amblyopia.
- CPT code numbers provide the most widely recognized pathway to report medical procedures and services for processing claims, conduct research, evaluate
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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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Talking about Cybersecurity Vulnerabilities in Medical Devices Shouldn’t be Taboo
According to the National Vulnerability Database, 18,353 vulnerabilities were reported in 2020. That’s nearly three times the volume of vulnerabilities reported five years ago, and higher than any year in the previous two decades. Given the rise in connected devices, this increase is not entirely unexpected. If that’s the case, shouldn’t we be seeing more vulnerability disclosures related to medical devices?
The U.S. Department of Homeland Security Cybersecurity and Infrastructure
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