BrightHeart has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI software to transform prenatal ultrasound evaluations of the fetal heart.
This development represents an advance in the detection of congenital heart defects (CHDs).
BrightHeart’s new AI software is designed to improve the accuracy of detecting morphological abnormalities indicative of coronary artery disease during ultrasound examinations of the fetal heart.
These studies are crucial as almost one in a hundred newborns suffer from coronary heart disease. Misdiagnosis or delay can lead to serious consequences.
BrightHeart’s technology is said to be tailor-made to fit seamlessly into today’s medical workflows, easing the pressure on overburdened sonographers and gynecologists.
The software automates required parts of the evaluation process, saving time and improving diagnostic precision in resource-constrained practices.
With FDA approval, BrightHeart is gearing up for commercial launch in the US, with the aim of expanding its business and introducing its advanced solution to clinics and hospitals across the country.
BrightHeart CEO Cécile Dupont said: “Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound.
“Our AI-powered solution not only helps doctors detect signs of possible abnormalities earlier, but also increases their confidence in confirming normal findings, which is equally critical to the peace of mind of expectant families.”
Paris-based BrightHeart is a medical device company and part of Sofinnova MD Start, an accelerator program of Sofinnova Partners.
BrightHeart Chairman Michael Butchko said: “Limited resources and workforce shortages are critical challenges in prenatal care, and we believe BrightHeart is uniquely positioned to address them.
“In this next phase, we want to deliver our transformative technology to physicians and expectant families, making a measurable impact on prenatal care outcomes.”
In May 2023, the company raised €2 million ($2.1 million) from Sofinnova Partners to develop its AI technology for detecting heart disease in fetuses.
“BrightHeart Receives 510(k) Clearance from the FDA for Prenatal Ultrasound Software” was originally created and published by Medical Device Network, a brand owned by GlobalData.
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