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  "description": "This French startup is turning one of medicine’s hardest screening problems into a routine exam and quietly redefining the standard of care.",
  "path": "/prenatal-ultrasound-reinvented-how-brightheart-ai-catches-90-of-deadly-fetal-heart-defects-before-birth/",
  "publishedAt": "2026-01-28T09:20:35.000Z",
  "site": "https://www.frenchtechjournal.com",
  "tags": [
    "BrightHeart",
    "**Cécile Dupont**",
    "Marilyne Lévy",
    "Bertrand Stos"
  ],
  "textContent": "One of the most tangible ways artificial intelligence is already reshaping healthcare is through medical imaging\n\nOver the past decade, MRI, CT, and ultrasound technologies have progressed dramatically, generating images of unprecedented quality and detail. But richer images also mean vastly more data. Interpreting billions of pixels at scale, consistently and accurately, remains a challenge no human can meet alone. That is where AI comes in.\n\nBy last year (2025), AI-enabled imaging solutions had become a $2.4 billion global market, driven largely by early disease detection and real-time clinical assistance. According to Global Growth Insights, the market should reach $26.5 billion by 2035.\n\nFrom oncology to cardiology, algorithms are increasingly being used not to replace clinicians, but to augment them - spotting subtle anomalies, ensuring exam completeness, and reducing the margin for error.\n\nIn prenatal medicine, where timing can change a life, those gains are particularly critical.\n\nEnter BrightHeart.\n\nThe BrightHeart team\n\n## **Turning complex fetal heart screening into a routine exam**\n\nBrightHeart is an AI-powered medical device designed to support gynecologists, obstetricians, and sonographers during prenatal ultrasound exams. Its focus is on one of the most complex and most frequently missed areas of prenatal screening: congenital heart defects (CHD).\n\nFounded in 2022 within Sofinnova Partners’ MD Startup Studio, BrightHeart was built at the intersection of clinical expertise and deep-tech execution. **Cécile Dupont**, CEO of BrightHeart and Partner at Sofinnova Partners, led the company. Her background combines engineering and medical training.\n\n“Detecting cardiac anomalies in utero is extremely difficult for clinicians who are not pediatric cardiologists,” Dupont said. “At three months of pregnancy, the fetal heart is about one centimeter in size, and historically, only around one third of cardiac anomalies are detected.”\n\nBrightHeart’s workflow solution uses AI to guide clinicians through the ultrasound exam, helping them capture the right views, validate exam completeness, and flag potential abnormalities without disrupting existing workflows.\n\nThe impact is significant:**fetal cardiac anomaly detection rates by those using the solution have improved from roughly 30% to over 95%, and in some settings exceeded 98%.**\n\n## **A clinical problem hiding in plain sight**\n\nThe idea behind BrightHeart originated at Necker Hospital in Paris, one of Europe’s leading pediatric centers. Pediatric cardiologists Marilyne Lévy and Bertrand Stos witnessed firsthand the consequences of missed prenatal diagnoses.\n\nAround 70% of congenital heart defects are not detected during pregnancy, even though they affect approximately 3% of births, making them more common than chromosomal conditions such as Down syndrome. While the fetus initially benefits from the mother’s circulation, the condition is often discovered only after birth, when oxygen deprivation can already have caused irreversible damage.\n\n“These babies arrive without warning,” Dupont said. “If severe heart disease is detected too late, the consequences can be devastating.”\n\nThe clinicians believed artificial intelligence could help close this diagnostic gap and approached Sofinnova with the concept. BrightHeart was created to translate the clinical reasoning of expert cardiologists into an intelligent algorithm capable of interpreting highly complex ultrasound images.\n\nThe original clinicians remained involved as advisors, while continuing their hospital practice.\n\nMarilyne Lévy and Bertrand Stos providing online training on detecting heart malformations\n\n## **A tablet, a checklist, and eight critical markers**\n\nBrightHeart’s technology is designed to fit seamlessly into existing clinical environments. The system relied on a tablet placed next to the ultrasound machine, connected securely to the cloud. During the exam, the software guides the sonographer through a structured checklist, ensuring all required views are captured.\n\n“The system doesn’t allow you to stop until the exam is complete,” Dupont explained.\n\nThe AI analyzes eight key pathological markers, using a color-coded system to indicate whether findings are normal, abnormal, or require further attention. This not only improved detection, but also reduced the need to recall patients due to incomplete exams - a major operational and emotional burden in prenatal care.\n\nImportantly, BrightHeart does not provide a diagnosis. It functions as a clinical decision-support tool. If warning signs appear, patients are referred to pediatric cardiologists for definitive diagnosis and care planning, including decisions about delivery in specialized Level 3 maternity units when needed.\n\nThe next version of the software is expected to operate in real time. “The tablet was a technical choice to standardize deployment and maintenance,” Dupont said. “But the solution itself is hardware-agnostic.”\n\n## **From regulatory hurdles to real-world impact**\n\nAs a regulated medical device, BrightHeart faces long development and validation timelines, including technical and clinical validation for FDA clearance.\n\nLike many French AI imaging startups, the company has chosen to expand first into the United States, where regulatory pathways are more predictable. Between early 2024 and mid-2025, BrightHeart began commercial deployment.\n\nOne of its earliest adopters is Carnegie in New York, the city’s largest obstetric ultrasound center. After one year of use, the results were striking: exam completion rates improved by 34%, liability risks were reduced, and exam time was shortened by at least five minutes. That efficiency gain compounded significantly across daily workflows.\n\nIn Europe, however, regulatory timelines are more challenging. The introduction of the Medical Device Regulation (MDR) has required all devices certified under the old CE mark to be re-certified, causing delays across the sector.\n\n“The process is extremely frustrating,” Dupont said. “But we are nearing approval.”\n\nOnce obtained, the company planned to prioritize France while evaluating other European markets where it could deliver the most impact.\n\n## **Building the standard of care, not just another tool**\n\nBrightHeart’s ambition is not incremental improvement, but standardization.\n\nThe company aims to make expert-level fetal heart screening as routine as Down syndrome screening is today. Its cloud-based platform covers the full workflow - from image acquisition to reporting - and is built on four pillars: clinical accuracy, workflow optimization, seamless integration with all ultrasound machines, and strong peer-reviewed clinical evidence.\n\nSo far, BrightHeart is the only company in its category with published peer-reviewed clinical results in leading obstetrical journals.\n\nThe long-term roadmap extended beyond the heart. “We started with the most complex organ,” Dupont said. “But our goal is to expand to all critical organs and make the prenatal exam both complete and faster.”\n\n## **A subscription model with measurable ROI**\n\nBrightHeart operates on a monthly subscription model, bundling both the tablet and the software. Pricing was not publicly disclosed due to competitive sensitivity, but the value proposition was clear.\n\nBy saving time, improving exam quality, and reducing recall rates, the platform allowed clinicians to increase throughput - even in healthcare systems without direct reimbursement for AI tools. In practice, the solution positively impacts both workflow efficiency and practitioner income.\n\nWhile competition in AI imaging is intensifying, BrightHeart remains uniquely focused on screening rather than diagnosis.\n\n“It’s becoming a very hot space,” Dupont said. “But the clinical need is real, and the bar for evidence is high.”\n\n## **€11 million to scale globally**\n\nBrightHeart has just announced the close of an €11 million Series A round co-led by Odyssée Venture and GO Capital, with participation from the Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club via Side Angels, Sofinnova Partners, and numerous clinicians and medtech entrepreneurs.\n\nThe funding was earmarked for product expansion, U.S. and European growth, and continued clinical validation. At the time, the company employed 10 people across France and the United States, spanning R&D, clinical affairs, and sales.\n\n“Our mission is to make AI the new standard of care in prenatal ultrasound,” Dupont said. “If we can detect severe heart disease before birth, we can change outcomes for babies and families at scale.”",
  "title": "Prenatal Ultrasound, Reinvented: How BrightHeart AI Catches over 95% of Deadly Fetal Heart Defects Before Birth",
  "updatedAt": "2026-01-28T10:20:35.448Z"
}