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BrightHeart

Category: AI in Healthcare

AI-powered prenatal ultrasound platform that helps clinicians detect congenital heart defects (CHDs) during routine fetal screening. BrightHeart was founded in 2022. The company is led by Cécile Dupont Redon. Based in Paris, France. Team size: 11-50. Total funding raised: $14.8M. Latest round: Series A. Key investors include Sofinnova Partners, Odyssée Venture, GO Capital, Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club via Side Angels.

Founded
2022
Headquarters
Paris, France
Team size
11-50
Total funding
$14.8M

Value proposition

Expert-level AI screening for congenital heart defects embedded directly into routine prenatal ultrasound workflows, improving detection accuracy, exam completeness, and diagnostic confidence without disrupting care delivery.

Products and solutions

B-Right AI Platform: B-Right Screen (AI analysis of structural markers to identify severe CHD signs) and B-Right Views (automated protocol completion tracking and standard fetal heart view detection).

Unique value

Only player in prenatal ultrasound AI with published peer-reviewed clinical evidence (Obstetrics & Gynecology), 5 FDA clearances, and CE marking — delivering expert-level CHD screening that catches ~96% of major CHDs while reducing false positives/negatives.

Target customer

OB-GYNs, sonographers, and maternal-fetal medicine departments at hospitals and imaging centers performing prenatal ultrasound.

Industries served

Prenatal/maternal-fetal healthcare, obstetrics & gynecology, medical imaging (ultrasound).

Technology advantage

Standalone, plug-and-play AI platform compatible with major ultrasound manufacturers; FDA 510(k)-cleared and CE-marked (Class IIa); peer-reviewed clinical validation; seamless integration into existing workflows and reporting software.

How they differentiate

Differentiates via published peer-reviewed clinical evidence (only player in the field), multiple FDA clearances, and a standalone platform that integrates with any major ultrasound vendor, including GE Voluson.

Main competitors

Diagnoly (Fetoly), other prenatal ultrasound AI developers

Key partnerships

GE HealthCare (B-Right AI Platform integrated into Voluson Solution Store), Mount Sinai Health System (first NYC adopter), academic centers, Mussallem CHD Alliance.

Notable customers

Mount Sinai Health System (first NYC adopter), Carnegie Imaging for Women, Center for Fetal Medicine & Women's Ultrasound (Dr. Lawrence Platt)

Major milestones

Founded 2022 within Sofinnova MD Start Studio, €2M seed (May 2023), first FDA 510(k) clearance (Nov 2024), 5 FDA clearances and 2 peer-reviewed publications (2025), €11M Series A (Jan 2026), GE Voluson Solution Store integration (Feb 2026), CE mark and European launch (June 2026).

Growth metrics

5 FDA clearances (2025); 2 peer-reviewed publications in Obstetrics & Gynecology; ~96% detection of major CHDs; 88% reduction in false-positive errors; 70% reduction in false-negative errors.

Market positioning

Global leader in AI solutions for prenatal ultrasound, focused on congenital heart defect detection; scaling US commercialization and European expansion.

Geographic focus

US (commercialization) and Europe (expansion); HQ in Paris, France.

Patents and IP

Multiple US patents assigned to BrightHeart SAS on AI detection of fetal CHD from ultrasound, including US12343197B2 (granted Jul 1, 2025; systems/methods for improving detection of fetal CHD) and US12493962B2 (granted Dec 9, 2025; spatiotemporal neural networks for cardiovascular anomalies); related family includes US11869188B1, US12082969B1, US11875507B1, US12148162B2. Company patent page: brightheart.ai/patents. ~10 registered patents (IPqwery/Crunchbase).

About Cécile Dupont Redon

Partner at Sofinnova Partners (MD Start strategy, since 2019); CEO of BrightHeart since Nov 2022; Université de Technologie de Compiègne. Previously took C-suite roles at three Sofinnova medtech startups.

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