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 – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.
Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.