BrightHeart has secured FDA 510(k) clearance for its AI-driven software designed to transform prenatal ultrasound evaluations of the fetal heart. This advancement aims to improve the detection of congenital heart defects (CHDs), which affect approximately one in 100 newborns, and where misdiagnosis or delays can lead to severe consequences.
The AI software is engineered to enhance the accuracy of identifying morphological abnormalities indicative of CHDs during fetal heart ultrasound exams. By automating key parts of the evaluation process, the technology saves time and boosts diagnostic precision, particularly in settings with limited resources.
Addressing Resource Constraints in Prenatal Care
BrightHeart's technology is designed to integrate smoothly into current medical workflows, thereby reducing the burden on sonographers and OB/GYNs. According to BrightHeart chairman Michael Butchko, resource constraints and workforce shortages pose critical challenges in prenatal care, and BrightHeart is uniquely positioned to address them.
Cécile Dupont, CEO of BrightHeart, stated that their AI-powered solution assists clinicians in detecting potential abnormalities earlier and enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.
Commercial Launch and Future Plans
With FDA clearance, BrightHeart is preparing for its commercial launch in the US, with plans to expand its operations and introduce its advanced solution to clinics and hospitals across the country. The company aims to deliver its transformative technology to clinicians and expectant families, making a measurable impact on prenatal care outcomes.
BrightHeart, based in Paris, is a medical device company and part of Sofinnova MD Start, an accelerator program by Sofinnova Partners. In May 2023, the company raised €2m ($2.1m) from Sofinnova Partners to further develop its AI technology for detecting heart conditions in fetuses.
