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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The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software…
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The Drug Enforcement Administration says that criminals who have been committing prescription drug fraud are now using EHRs and e-prescribing systems to create bogus prescriptions that are often sent to pharmacies all…
What You Should Know:
– Soda Health, a health tech company transforming the way healthcare benefits are utilized, has announced a $50 million Series B funding round led by General Catalyst, with participation from former…
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What You Should Know:
– Xsolis, a provider of AI-driven solutions for healthcare administration, has announced the launch of a new generative AI platform designed to streamline the appeals process for healthcare providers.
– MultiCare Health…
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System C is trialling an AI assistant for social care in the NHS, developed in partnership with Microsoft to support social care practitioners by reducing their admin burden.
The technology, which will be available within…
East Sussex Healthcare NHS Trust has become the latest acute trust to select Nervecentre as its preferred supplier for an electronic patient record (EPR).
After a detailed tendering process, the trust chose Nervecentre to drive…
South Korean medical imaging AI company Neurophet has received second clearance for its brain image analysis software in the United States.It obtained another 510(k) from the US Food and Drug Administration for the latest…
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Vuno receives second 510(k)South Korean medical AI company Vuno has obtained a 510(k) clearance from the United States Food and Drug Administration for its chest X-ray analysis AI software.
The VunoMed Chest X-ray Triage quickly…
Several telehealth advocates are coming out in support of the Drug Enforcement Administration’s (DEA) third extension of Covid-19 telehealth flexibilities for the prescribing of controlled substances. However, they argue that more work needs to…
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