FDA grants clearance to 1st AI software for fetal heart evaluations

Medical devicemaker BrightHeart has earned FDA clearance for its artificial intelligence software designed to transform prenatal ultrasound evaluations of the fetal heart.

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Congenital heart defects impact approximately 1 in 100 newborns. These defects can be detected during a fetal heart ultrasound exam, according to a Nov. 18 press release. 

Misdetection or delayed diagnosis of heart defects can lead to severe consequences and missed opportunities for life-saving interventions. 

BrightHeart’s new AI software offers a solution to some of these challenges, allowing clinicians in resource-constrained practices to improve the detection of morphological abnormalities suggestive of CHDs.

The technology is designed to integrate into existing workflows to help reduce the burden of sonographers and OB-GYNs.

BrightHeart was founded just two years ago by pediatric cardiologists Marilyne Levy, MD, and Bertrand Sto, MD. 

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