This week has seen new vendor announcements for an array of artificial intelligence use cases: enhanced population health management on the county level and a New York University Langone Health spinoff focused on leveraging physics…
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FibriCheck, a DigitalHealth.London Accelerator alumnus company, announce their Food and Drug Administration (FDA) clearance and the commercial launch of their technology within the US. Their medically certified technology utilises consumer devices and redefines how…
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Former US Food and Drug Administration Commissioner Scott Gottlieb, MD published a call to action this week in JAMA Health Forum that asks Congress to update FDA regulations for medical AI. He begins the…
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Amid a national reckoning with racism spurred by the COVID-19 death rate among Black Americans, the U.S. Food and Drug Administration’s standards for pulse oximeters – those all-too-common devices that use light to measure…
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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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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…
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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When the U.S. Food and Drug Administration set to track COVID-19 vaccine deployment, it needed timely and robust information. Wanting the ability to scale, the FDA turned to next-generation exchange in the Fast Healthcare…
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South Korea OKs new stroke prediction AI softwareSouth Korea’s Ministry of Food and Drug Safety has recently approved an AI-based software for predicting the onset of ischemic stroke or cerebral infarction.
The NNS-SOT software, developed…
During the House Energy and Commerce Health Subcommittee hearing on the U.S. Food and Drug Administration’s regulation of drugs, biologics and medical devices on Wednesday, representatives fired questions at FDA directors. The lawmakers said they…
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