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| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
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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FDA Approves First Ortho-K Contact Lens to Manage Myopia
What You Should Know: - Today, Johnson & Johnson Vision announced that the U.S. Food and Drug Administration (FDA) has approved ACUVUE® Abiliti™ Overnight Therapeutic Lenses, the first and only orthokeratology (ortho-k) contact lens for the management of myopia. - Myopia, or ‘nearsightedness,’ is a chronic and progressive disease. Research shows that myopia will affect half of the world’s population by 2050,
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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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To Advance Health Equity, Put Real-World Cancer Data to Work
Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — like institutional racism and poverty — are a reflection of our broader society. Other inequities may go unrecognized but are no less damaging. People with underlying health conditions, for example, may be excluded from clinical trials, preventing them from accessing leading-edge treatments and limiting the evidence available to guide their care. With multiple drivers of
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