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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What You Should Know: – COTA, a leader in real-world data and analytics solutions, today announced a five-year extension of its research collaboration with the U.S. Food and Drug Administration’s (FDA) Oncology Center of…
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The demand for home sleep apnea testing (HSAT) devices is escalating, particularly in the context of the coronavirus 2019 (COVID-19) pandemic. The absence of standardized development and verification procedures poses a significant challenge. This…
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The integration of robotics in surgery has increased over the past decade, and advances in the autonomous capabilities of surgical robots have paralleled that of assistive and industrial robots. However, classification and regulatory frameworks…
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The Food and Drug Administration (FDA) announced the launch of a new initiative, Home as a Health Care Hub, that focuses on using augmented reality and virtual reality to improve health equity by reimagining…
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