What You Should Know:
– X-trodes, a pioneer in wireless monitoring solutions, has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Smart Skin solution, marketed as…
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What You Should Know:
Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq® AP-Dx*. The digital pathology solution…
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What You Should Know:
– Samsung’s Galaxy Watch has received De Novo authorization from the US Food and Drug Administration (FDA) for its sleep apnea detection feature.
– This marks a significant step forward in wearable…
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Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents…
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Doctors and researchers from the University of Maryland School of Medicine, the UMD Institute for Health Computing and the VA Maryland Healthcare System are concerned that large language models summarizing clinical data could meet…
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What You Should Know:
– 23andMe Holding Co. (Nasdaq: ME), a genetics and biopharmaceutical company, announced The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for 23ME-01473 (referred to…
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By Hannah Nelson
January 31, 2024 – While generative AI shows promise for EHR data summarization, using large language models (LLMs) to summarize clinical data brings risks that are not clearly covered by existing Food and…
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What You Should Know:
– Deliberate AI, a digital health company harnessing AI to revolutionize mental health assessment, has secured a major milestone in its mission. The U.S. Food and Drug Administration (FDA) has selected…
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What You Should Know:
– Thirona, a pioneer in AI-powered lung analysis, received a major boost for its cutting-edge technology LungQ™ with the U.S. Food and Drug Administration (FDA) 510(k) clearance for its latest update,…
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What You Should Know:
Medtronic, a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval of its Percept™ RC Deep Brain Stimulation (DBS) system.The rechargeable neurostimulator is the latest…
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