Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base
The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.
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A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
A year after Congress officially gave the FDA the power to ban devices for a specific use, the school that inspired the new law is taking the agency back to court on allegations it has failed to respond to document requests.