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.
You may also be interested in...
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.
The app allegedly shared sensitive customer information with three China-based data analysis and collection firms.
The regulatory tools are for use in medical device development.