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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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
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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AppliedVR Lands $29M for VR Platform to Treat Chronic Pain
What You Should Know: - AppliedVR, a Los Angeles, CA-based company advancing the next generation of digital medicine, today announced $29 million in Series A funding, bringing its total funds raised to date to $35 million. The round, which includes key investors F-Prime Capital, JAZZ Venture Partners, Sway Ventures, GSR Ventures, Magnetic Ventures and Cedars-Sinai, will fuel the company’s growth as it pursues full FDA approval over the next year. - Founded in 2015, AppliedVR provides
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3 Ways Providers Can Navigate COVID-19 Vaccination Rollout Successfully
The New Year brings hope and promises that an end to the COVID-19 pandemic is in sight. With two vaccines authorized by the FDA for emergency use, and close to 3 million healthcare workers already vaccinated, there is hope that this virus will be eradicated and life will begin to return to normal by year’s end. However, for the frontline healthcare workers still treating escalating case volumes, the physical and emotional toll is devastating. With another surge forecasted for
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Spectrum Health Taps TytoCare to Expand Telehealth Offerings
What You Should Know: - Spectrum Health, a not-for-profit, integrated health system based in West Michigan has announced a partnership with TytoCare to expand their telehealth offerings. - The integration of TytoCare into Spectrum Health’s virtual care offering will enhance the health system’s ability to diagnose and treat patients remotely with in-depth, physical examinations during video visits. In an initial pilot with Spectrum Health employees
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AI-Powered COVID-19 Solution Reduces Report Turnaround Times by 30%, Study Finds
What You Should Know: - The Moscow Center for Diagnostics & Telemedicine found that the introduction of RADLogics’ AI-Powered solution into radiology workflow to analyze Chest-CT scans during the COVID-19 pandemic reduced report turnaround time by an average of 30 percent, which is equivalent to 7 minutes per case. - The study was conducted over two separate phases with the first taking place between April 30, 2020 to June 18, 2020 and the second taking place between June 18, 2020 to
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