Introduction
Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, has made a significant move to bolster its leadership team by appointing Teri Thomas as Chief Business Officer (CBO) of its Cancer…
Mickey Tripathi, U.S. National Coordinator for Health IT, and Troy Tazbaz, the U.S. Food and Drug Administration’s digital health director, stepped down from the Coalition for Health AI last week. While the announcement followed concerns…
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What You Should Know:
– Eli Lilly’s Kisunla™ (donanemab-azbt) has been approved by the FDA as a treatment for adults in the early stages of Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI)…
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Introduction
Clarius Mobile Health has recently announced that it has obtained U.S. Food and Drug Administration (FDA) clearance for its latest innovation, the Clarius OB AI fetal biometric measurement tool. This development marks a significant…
What You Should Know:
– ColdVentures, a medical device innovator, has unveiled the ColdVest – a groundbreaking wearable technology designed to prevent heat stroke fatalities.
– The ColdVest is the first-of-its-kind, Class 1 FDA-approved portable emergency…
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The Medicines and Healthcare products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices focusing on transparency.The guidance on the transparency of machine learning medical devices, published on 13 June 2024,…
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News
Republican lawmakers criticize the FDA’s partnership with the Coalition for Health AI for testing healthcare AI products, raising concerns that CHAI’s members include Microsoft and Google as well as large health systems that are…
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In 2023, the FDA identified 62 medical device recalls with 42 identified to date in 2024. Most recently, Tandem Diabetes Care recalled its Apple iOS app after over 200 reported injuries. While the issues…
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What You Should Know:
– ALZpath, a leader in Alzheimer’s disease diagnostics, announced a licensing agreement with Roche for their innovative pTau217 antibody. This paves the way for a blood test to diagnose Alzheimer’s disease…
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There is a significant unmet need for effective brain monitoring across various healthcare settings — including emergency departments, intensive care units, outpatient clinics and home environments — due in large part to the persisting…
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