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BrightHeart has developed an FDA-cleared artificial intelligence platform that analyzes fetal heart ultrasound exams in real time to support clinicians and sonographers. The technology addresses the high rate of undetected congenital heart defects during routine prenatal ultrasounds by providing automated feedback on exam completeness and flagging potential structural abnormalities suggestive of CHDs. The system is designed for seamless integration into existing workflows via cart-side tablets or reporting software, with multiple FDA clearances achieved rapidly. Early pilot programs have demonstrated improved workflow efficiency and diagnostic confidence among clinicians. A limited market release is underway.
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