BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations

PARIS--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA 510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the fetal heart. This milestone marks a significant breakthrough in one of the most challenging and critical areas of prenatal care.

Fetal heart ultrasounds exams are essential for detecting congenital heart defects (CHDs), which are the most common type of birth defect, affecting nearly 1 in 100 newborns. However, misdetection or delayed diagnosis can lead to severe consequences, including missed opportunities for life-saving interventions. BrightHeart’s AI software offers an innovative solution to these challenges, enabling clinicians to improve the detection of morphological abnormalities suggestive of CHDs, in resource-constrained practices.

“Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, BrightHeart CEO and a Partner at Sofinnova Partners' medtech accelerator, MD Start. “Our AI-powered solution not only assists clinicians in detecting signs of potential abnormalities earlier but also enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.”

BrightHeart’s technology is designed to integrate seamlessly into existing workflows, reducing the burden on overworked sonographers and OB/GYNs. By automating key aspects of the evaluation process, the software has the ability to save time and improve accuracy, in increasingly resource-constrained practices.

Developed at Record Speed
Founded just two years ago, on an idea by pediatric cardiologists, Dr. Marilyne Levy and Dr. Bertrand Stos, BrightHeart has achieved this milestone at an unprecedented pace, showcasing the dedication of its expert team and the power of cutting-edge AI technology. “We’ve moved from concept to FDA clearance in record time, demonstrating the potential of our product and the agility and commitment of our team,” added Cécile Dupont.

Positioned for Growth
With FDA clearance secured, BrightHeart is poised for its U.S. commercial launch, driving efforts to scale operations, enter the market and showcase its groundbreaking solution in clinics and hospitals across the country.

“Resource constraints and workforce shortages are critical challenges in prenatal care, and we believe BrightHeart is uniquely positioned to address them,” said Michael Butchko, Chairman of BrightHeart. “In this next phase, we aim to deliver our transformative technology to clinicians and expectant families, making a measurable impact on prenatal care outcomes.”

About BrightHeart
BrightHeart SAS is a Paris-based, privately held, medical device company and part of Sofinnova MD Start, Sofinnova Partners' medical device accelerator. The company’s software uses cutting-edge artificial intelligence to analyze fetal heart ultrasound exams and support clinicians with the prenatal identification of congenital heart defects. The technology aims to improve pregnancy outcomes by anticipating delivery care and early intervention.

BrightHeart builds on an idea by Dr. Marilyne Levy and Dr. Bertrand Stos, two leading fetal cardiologists based in Paris, France.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical, and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €2.8 billion under management. For more information, please visit: www.sofinnovapartners.com.

Contacts

Cécile Dupont
Chief Executive Officer, BrightHeart
cecile@brightheart.fr