A South Korean manufacturer which claims to develop the world’s first AI-powered doll companion for seniors has recently registered its product in the United States. Hyodol has recently announced that its AI companion doll of…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
