HIMSSCast: Should GPT-5 be HIPAA compliant, FDA regulated?
HIMSSCast: Should GPT-5 be HIPAA compliant, FDA regulated? | MobiHealthNews
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Tag: FDA
FDA Clears Ceribell’s AI-Powered EEG as First Device for Continuous Delirium Monitoring
What You Should Know:
– Ceribell, Inc. has secured FDA 510(k) clearance for the world’s first continuous, AI-powered delirium monitoring solution, expanding its existing EEG platform beyond seizure detection.
– The technology addresses a massive gap…
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a2z Radiology AI Secures $4.5M Seed to Scale the First Comprehensive Abdomen-Pelvis CT Triage System
What You Should Know:
– a2z Radiology AI has raised $4.5M in seed funding led by Khosla Ventures and SeaX Ventures to accelerate the rollout of its FDA-cleared triage system. Unlike existing tools that flag…
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FDA Qualifies PathAI’s AIM-MASH as First AI-Powered Pathology Drug Development Tool
What You Should Know:
– PathAI has secured a historic regulatory milestone with the FDA qualification of its AIM-MASH AI Assist tool, making it the first AI-powered pathology biomarker to receive such status under the…
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FDA announces TEMPO, a new pilot to tackle chronic disease with tech
FDA announces TEMPO, a new pilot to tackle chronic disease with tech | Healthcare IT News
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News 12/5/25
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The Spokesman-Review and The Washington Post say that the VA remains on track to expand its Oracle Health EHR rollout to 13 more medical centers in 2026 despite the problems that…
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HHS Launches ‘OneHHS’ AI Strategy to Integrate AI Across CDC, CMS, and FDA for Efficiency and Public Trust
What You Should Know:
– The U.S. Department of Health and Human Services (HHS) has released its comprehensive AI Strategy, fulfilling the Trump Administration’s commitment to utilize leading technologies across the federal workforce.
– The “OneHHS”…
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Healthcare AI News 12/3/25
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Surveyed provider executives expect the chief AI innovation officer to become the most important new C-suite role, and most say that the chief AI officer and the CIO / CTO positions are rising fastest…
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News 12/3/25
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A new, 10-year CMS model called ACCESS will test whether an outcome-aligned payment approach can expand access to technology-enabled chronic care management in Original Medicare starting in July 2026.
CMS says that…
RapidAI Secures FDA Clearance for Five New Deep Clinical AI Modules, Expanding Enterprise Imaging Platform
What You Should Know:
– RapidAI, a pioneer in deep clinical AI, announced U.S. FDA clearance for five new imaging modules—Rapid DeltaFuse™, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic for measurement.
– The expansion…
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