Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease that impacts an estimated 80 million people in the United States and nearly 1 billion globally. Untreated OSA carries profound health and quality-of-life…
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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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Here is where we will explore the top EHR vendors, focusing on those who specialize in either enterprise wide systems, or electronic health records for physician practice offices. Since one of the goals of…
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Cisco has announced a joint initiative with the University of Galway and CÚRAM SFI Research Centre for Medical Devices, to create a research framework for a ‘virtual hospital’.
The pilot, which is part of Cisco’s…
The current healthcare systems in the U.S. often compartmentalize health conditions, treating physical and mental health as distinct entities. This dissociative approach has led to a limited perspective on diabetes treatment focused largely on…
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For years, the relationship between patients and healthcare professionals has hinged on trust. We, the professionals — whether doctors, nurses, dietitians, or therapists — invest time, effort, and countless hours in honing our skills….
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Exclusive: NHS England will consult on controversial plans to consolidate patient data from England’s clinical registries in a single platform, following opposition from patient groups.
In 2022, NHSE announced that it would combine more…
The Medicines and Healthcare products Regulatory Agency (MHRA) has selected five technologies for its AI Airlock, a pilot scheme launched to better understand how we can regulate AI powered medical devices.
AI Airlock, which launched…
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.”This final guidance is part…
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