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…
In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the agency…
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It’s not an easy question to answer, but with a well thought out roadmap, it’s doable.
By John Halamka, M.D., President, Mayo Clinic Platform and Paul Cerrato, MA, senior research analyst and communications specialist, Mayo…
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In a suit filed against CVS, Walgreens, GE Healthcare and many other medical technology companies and sellers of pulse oximeters – devices that use light to measure oxygen saturation in the blood – Medtronic…
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This week at the HLTH conference in Las Vegas, FDA Commissioner Robert Califf sat down with John Brownstein, chief innovation officer at Boston Children’s Hospital, to discuss the current state of healthcare AI, as…
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Introduction
Artificial Intelligence (AI) is rapidly transforming healthcare, offering revolutionary tools for diagnosis, treatment, and patient care. However, the complexity and potential risks associated with AI necessitate robust regulation to ensure its safe and effective…
The Food and Drug Administration (FDA) has released its perspective on regulating AI in healthcare and biomedicine, stating that oversight needs to be coordinated across all regulated industries, international organizations and the U.S. government. The…
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ASX-listed Echo IQ has obtained regulatory approval in the United States for its AI-driven solution that supports structural heart disease diagnosis.WHAT IT’S ABOUT
Two years since coming to the US, the company has now received…
What You Should Know:
– GE HealthCare announced today that its MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer’s disease.
–…
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Medical imaging technology is advancing at an unprecedented rate, and AI tools are increasingly making their way into healthcare systems, offering quicker and more accurate diagnoses. One such tool is the CINA-CSpine algorithm, designed…
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