News
FDA issues draft guidance for supporting development and marketing of AI-enabled devices throughout the Total Product Life Cycle. It also publishes draft guidance for the use of AI to support development of drugs and…
The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones.The guidance, Pulse Oximeters for Medical Purposes -…
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The U.S. Food and Drug Administration is seeking public comment on new recommendations for non-clinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a…
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Essential FDA Guidelines Transform AI Medical Devices
Revolutionary Changes in Medical Device Regulation
The U.S. Food and Drug Administration is introducing groundbreaking marketing submission recommendations for AI-enhanced medical devices. These guidelines will provide comprehensive oversight throughout…
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission recommendations, including the documentation and information needed…
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This roundup is meant to highlight some of the most notable funding rounds of the month and is not intended to be comprehensive.
Health tech companies made several major funding announcements in December. Here is…
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ŌURA, a wearable device company, has secured $200 million in Series D funding to expand its product offerings, the company announced last week.
ŌURA, which was founded in Finland in 2013, offers a wearable smart…
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Cloud platform provider for the property and casualty (P&C) insurance economy business, CCC Intelligent Solutions (a subsidiary of CCC Intelligent Solutions Holdings), has acquired EvolutionIQ, a platform for AI-powered guidance for disability and injury…
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Researchers concluded that the strong performance of GPT-4 large language models (LLMs) suggests their potential as a tool to help fill gaps in physicians’ knowledge and aid in diagnosing medical conditions in the future,…
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What You Should Know:
– Scripta Insights, an AI-powered pharmacy navigation platform, has secured $17M in Series B funding led by Aquiline, a private investment firm specializing in financial services and technology.
– The latest investment…
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