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    Sofinnova MD Start

    BrightHeart Expands Its AI Platform in Europe to Bring Greater Confidence and Consistency to Prenatal Ultrasound

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    BrightHeart

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    MD Start

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    Cécile Dupont

    Available November 3, the expanded B-Right AI Platform helps clinicians deliver more complete prenatal examinations, with advanced fetal heart and brain assessment support and a more efficient workflow.

    PARIS, FRANCE — November 3, 2026 — BrightHeart, a leader in AI for prenatal ultrasound, today announced the European launch of its expanded B-Right AI Platform, designed to help obstetrician-gynecologists and midwives perform more complete, consistent prenatal examinations with greater confidence and less manual work.

    Building on its clinically backed fetal heart screening technology, the platform now extends AI-powered support across the full anatomy scan, including advanced fetal brain assessment, while introducing a streamlined HDMI-connected workflow.

    Greater confidence in every examination

    Prenatal ultrasound is a technically demanding examination, where image quality, fetal position, and operator experience can influence the completeness and consistency of assessments.

    B-Right Views helps clinicians assess exam completeness by automatically recognizing 27 standard fetal ultrasound views, tracking progress, and evaluating clinically relevant image-quality criteria. Semi-automated measurements and quality feedback provide additional support, helping practitioners, particularly those with less experience, approach examinations with greater confidence.

    “Every obstetrician-gynecologist and midwife should feel confident that they have performed a thorough, high-quality examination, regardless of their level of experience,” said Cécile Dupont, CEO of BrightHeart and Partner at Sofinnova Partners. “Our ambition is to make expert-level support more accessible, while reducing the manual workload that comes with every scan.”

    Bringing advanced clinical expertise into routine practice

    Beyond exam completeness, BrightHeart provides focused support for the evaluation of critical fetal organs. B-Right Screen assists clinicians in identifying findings suggestive of severe congenital heart defects (CHDs), based on eight expert-defined structural markers associated with numerous signs of congenital heart conditions.

    BrightHeart's fetal heart technology is supported by two peer-reviewed studies published in Obstetrics & Gynecology. In a multicenter validation involving 877 examinations, the software demonstrated 98.7% sensitivity and 97.7% specificity among examinations with conclusive results for identifying findings concerning major CHDs.
    Furthermore, the expanded platform also introduces fetal brain assessment capabilities, combining standardized measurements with anatomical quality criteria to support more comprehensive evaluations.

    Professor Laurent Salomon, fetal medicine specialist and Clinical Advisor to BrightHeart, added: “Assessment of the fetal central nervous system is technically demanding and highly dependent on operator expertise. Bringing structured measurement support and quality feedback into this examination, in the same way BrightHeart has done for the fetal heart, has real potential to improve the consistency and completeness of prenatal screening at scale.”

    Less manual work, more focus on patients

    The expanded version also introduces HDMI connectivity, enabling the platform to recognize standard views and extract relevant images as the examination progresses, reducing manual image capture and documentation steps.

    Complementing its existing DICOM-based connectivity, this new workflow integrates AI assistance more naturally into routine scanning. Both configurations use cloud processing and support examination review through the B-Right App on the tablet and Web Viewer, helping clinicians streamline their workflow from acquisition to reporting.

    The expanded B-Right AI Platform will be available in Europe starting November 3, 2026.

    Learn more at www.brightheart.ai.

    About BrightHeart

    Co-founded by pediatric cardiologists Dr. Marilyne Lévy and Dr. Bertrand Stos, BrightHeart develops AI software to advance prenatal ultrasound screening. Its B-Right AI Platform combines full-anatomy scan support with focused fetal heart screening capabilities, helping clinicians perform more complete, consistent examinations. BrightHeart's portfolio includes FDA-cleared and CE-marked medical devices, with intended uses and availability varying by market.

    Regulatory note: B-Right AI Platform is an umbrella marketing term encompassing BrightHeart's B-Right solutions. Certain new B-Right Views features are not commercially available in the United States. Refer to brightheart.ai for country-specific regulatory information.

    Scientific references

    Zelop CM et al. Obstetrics & Gynecology (2026). https://doi.org/10.1097/AOG.0000000000006027

    Lam-Rachlin J et al. Obstetrics & Gynecology (2026). https://doi.org/10.1097/AOG.0000000000006087