The U.S. Food and Drug Administration’s Center for Devices and Radiological Health is asking the public to consider disease burden, technology and other factors in the design of clinical studies that adequately reflect the…
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SONU is the First Over-the-Counter Device Authorized for At-Home Use that Extends the Toolbox of Treatment Options for Patients and Physicians and Offers a Safe Alternative to Pharmaceutical Treatments
SoundHealth, Inc., a medical technology company…
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– Luminopia, a digital health company focused on treating neuro-visual disorders, announced today that Highmark has approved coverage for its FDA-cleared therapy for children with amblyopia.
– This decision marks a significant…
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Eko Health outfits LSU Athletic Sports Medicine team with CORE 500 digital stethoscopes and AI algorithms for the enhanced detection of cardiac conditions during athlete physical exams What You Should Know: – Eko Health,…
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Healthcare providers should actively pursue the integration of generative AI and natural language processing (NLP) tools. However, it is crucial to rigorously validate the performance of each system before its widespread use, advises Dr….
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When ChatGPT demonstrated its ability to respond to plain English questions, it marked a significant milestone in AI development. Yet despite this, and more than 700 FDA-approved AI applications, healthcare adoption remains limited.Dr. Ronald…
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Andy Molnar, CEO of the Digital Therapeutics Alliance, has been selected as an industry representative for the FDA’s Digital Health Advisory Committee (DHAC). The FDA established the DHAC to ensure safe and effective regulation of…
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What You Should Know: – TytoCare, a virtual care company enabling accessible, high-quality primary care from home, announced today that it has received an additional FDA clearance for a new AI-powered diagnostic capability, Tyto Insights…
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Axena Health, which makes a digital therapeutic for women’s pelvic health, has partnered with the direct-to-consumer telehealth company UpScriptHealth to offer consultation and treatment to women suffering from urinary incontinence symptoms.Axena’s Leva Pelvic Health…
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What You Should Know: – LG Electronics launches its latest addition to its diagnostic monitor lineup, the 21HQ613D-B. This 21.3-inch 5-megapixel (MP) IPS monitor has received FDA clearance for digital mammography and breast tomosynthesis. …
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