From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The…
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Hyperfine, Inc. has gained FDA approval for its latest software update, integrating advanced AI algorithms to enhance image quality across all sequences of its portable magnetic resonance brain imaging system, the Swoop. This update…
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What You Should Know: – The U.S. Food and Drug Administration (FDA) has formed a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital…
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FDA creates a nine-member Digital Health Advisory Committee that will advise it on topics such as AI, augmented and virtual reality, digital therapeutics, wearables, and remote patient monitoring technology.
Nominations will be accepted…
The U.S. Food and Drug Administration on Wednesday announced the creation of a new Digital Health Advisory Committee, which will gather “experts throughout the field who can help ensure our regulation of these exciting…
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Ontada, announced it was awarded a competitive contract with the U.S. Food and Drug Administration (FDA) to advance the use of real-world data (RWD) in the U.S. community oncology setting.Ontada will…
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RaySearch Laboratories AB is expanding its collaboration with P-Cure, a proton therapy provider, to integrate its RayStation and RayCare systems with P-Cure’s proton therapy system. This partnership enables seamless use of RaySearch’s automation, workflow…
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Autonomous artificial intelligence (AI) promises to increase healthcare productivity, but real-world evidence is lacking. We developed a clinic productivity model to generate testable hypotheses and study design for a preregistered cluster-randomized clinical trial, in…
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GT Medical Technologies, Inc. presented promising interim results from a multi-institutional study at ASTRO 2023, reinforcing the effectiveness and safety of GammaTile Therapy for recurrent brain metastases. The study involved 48 patients from 14…
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Unlock the latest breakthroughs in digital health with the September edition of Digital Health Digest! 🚀 Dive into a realm where technology meets healthcare, bringing you close to the recent advancements, collaborations, and regulatory…
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