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