FDA Clears AI That Estimates Due Dates From Ultrasound Images
Ultrasound AI just landed a De Novo clearance, the FDA pathway reserved for genuinely novel devices with no existing equivalent on the market. The tool predicts delivery dates from ultrasound images alone, no other clinical inputs needed. That matters most when standard methods struggle, particularly late in pregnancy or with atypical fetal measurements.
practitioners › Cloud-based SaMD powered by deep learning, cleared March 2, 2026 as an adjunct tool, not a standalone diagnostic.
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