News 12/5/25
Top News
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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Tag: FDA
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
News
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
Top News
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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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Ceribell Receives FDA Clearance for Clarity® AI, Becoming First Point-of-Care EEG for All Ages
What You Should Know:
– Ceribell, Inc. today announced that the U.S. FDA has granted 510(k) clearance for its next-generation Clarity® algorithm.
– The FDA clearance makes the Ceribell System the first and only AI-powered point-of-care…
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GE HealthCare Submits Photonova™ Spectra for FDA Clearance: Deep Silicon Detectors Power New PCCT System
What You Should Know:
– GE HealthCare has announced the submission of a 510(k) to the U.S. FDA for Photonova™ Spectra, its new photon-counting computed tomography (PCCT) system with advanced AI algorithms.
– Built on proprietary…
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11 Recent Digital Health FDA Clearances You Need to Know: AI, Wearables, and Robotics Drive Precision Medicine Forward
What You Should Know:
– The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.
– These FDA clearances reflect a deepening integration…
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Fibricheck detection capabilities for atrial fibrillation (FDA–AF): a multicenter validation study
Atrial fibrillation (AF) is the most common arrhythmia worldwide and is associated with significant morbidity and mortality. FibriCheck is a medical analysis platform that uses an end-to-end algorithm to detect AF based on photoplethysmography…
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Nanox Acquires VasoHealthcare IT for Up to $800K to Accelerate AI Deployment in U.S. Hospitals
What You Should Know:
– NANO-X IMAGING LTD has announced an agreement to acquire VasoHealthcare IT (VHC IT) from Vaso Corporation for up to $800k.
– The strategic acquisition is intended to accelerate the deployment of…
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