Products

Fetal EchoScan
Brightheart
Cardiology AI
Brightheart's Fetal EchoScan is an FDA-cleared AI-powered ultrasound screening software that assists clinicians in the prenatal detection of congenital heart defects, ensuring comprehensive exams and optimizing workflow.
BrightHeart View Classifier
BrightHeart
Cardiology AI
BrightHeart's B-Right AI Platform, including the B-Right Views tool, provides AI-powered guidance and analysis for prenatal ultrasound exams, enhancing the detection of congenital heart defects and ensuring exam completeness.

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About BrightHeart

BrightHeart is a healthcare AI company specializing in the development of artificial intelligence-driven ultrasound screening software for the prenatal detection of congenital heart defects (CHDs) in fetuses. Their flagship product, the B-Right AI platform, is designed to integrate seamlessly into existing clinical workflows, providing real-time guidance to sonographers and obstetricians during fetal heart ultrasound exams. The software assists in consistently capturing the necessary anatomical views, validating exam completeness, and flagging potential morphological abnormalities suggestive of CHDs, thereby augmenting clinician capabilities and reducing the margin for error in a technically demanding area of prenatal care.

The company’s technology aims to standardize expert-level fetal heart screening, ultimately improving diagnostic accuracy and enabling earlier intervention and optimized management of pregnancies and deliveries for affected newborns. BrightHeart has secured multiple FDA clearances for its AI software, allowing for commercial deployment in the U.S. and expansion across Europe. Clinical studies have demonstrated that BrightHeart’s AI software can improve detection rates and enhance efficiency in prenatal ultrasound evaluations.

Focus Areas

Prenatal ultrasound congenital heart defects (CHD) detection fetal heart screening obstetrics pediatric cardiology AI-driven medical imaging

Business Intelligence

Key InvestorsOdyssée Venture, GO Capital, Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club via Side Angels, Sofinnova Partners, Professor Laurent Salomon, Sacha Loiseau, John Gridley
PartnershipsGE HealthCare's Voluson™ Solution Store, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital, Carnegie Imaging for Women
TechnologyB-Right AI Platform, cloud-native, seamlessly integrates into existing ultrasound workflows as a plug-and-play solution, compatible with major ultrasound manufacturers and reporting solutions, offers automatic display on cart-side tablets and detailed assessments on a standalone web platform. Utilizes NVIDIA L4 Tensor Core GPUs in the cloud through AWS, NVIDIA CUDA Toolkit, NVIDIA cuDNN, and Meta's DINOv2 model for self-supervised learning.
FDA Clearances5 cleared products (estimated)

What Physicians Need to Know

Prenatal Ultrasound & Fetal Heart Screening
Specializes in high-resolution prenatal ultrasound, offering advanced fetal heart screening to identify potential issues early in gestation. This enables timely intervention and comprehensive counseling for expectant parents.
Congenital Heart Defect (CHD) Detection
Leverages cutting-edge AI to enhance the accuracy and speed of congenital heart defect detection, providing detailed anatomical and functional assessments critical for early diagnosis and management planning.
Obstetrics Integration
Seamlessly integrates advanced fetal imaging and CHD screening into routine obstetric care workflows, providing obstetricians with enhanced diagnostic tools and insights for improved maternal and fetal outcomes.
Pediatric Cardiology Collaboration
Facilitates a smooth transition of care by providing comprehensive reports and insights directly relevant to pediatric cardiologists, ensuring continuity and specialized management for infants diagnosed with CHD.
AI-Driven Medical Imaging
Utilizes proprietary AI algorithms to analyze ultrasound images, reducing inter-observer variability, highlighting subtle anomalies, and improving diagnostic confidence and efficiency for clinicians.
Physician Tip

BrightHeart offers a powerful suite of tools designed to elevate your diagnostic capabilities in prenatal care. For obstetricians, the AI-driven screening can significantly enhance early detection of CHDs, allowing for more informed patient counseling and referral. Pediatric cardiologists will benefit from the detailed, standardized reports that streamline pre-natal consultations and post-natal care planning. The AI's ability to reduce scan times and improve accuracy can lead to better patient throughput and reduced diagnostic uncertainty. Consider how integrating this technology can optimize your workflow and improve patient outcomes by enabling earlier and more precise interventions.

BrightHeart's platform is designed for robust integration with existing Electronic Health Record (EHR) systems and Picture Archiving and Communication Systems (PACS) to ensure a seamless flow of patient data and imaging results, minimizing manual data entry and maximizing efficiency for clinical teams.

Products by BrightHeart

2 products in the directory

Fetal EchoScan
Brightheart
Cardiology AI
Brightheart's Fetal EchoScan is an FDA-cleared AI-powered ultrasound screening software that assists clinicians in the prenatal detection of congenital heart defects, ensuring comprehensive exams and optimizing workflow.
BrightHeart View Classifier
BrightHeart
Cardiology AI
BrightHeart's B-Right AI Platform, including the B-Right Views tool, provides AI-powered guidance and analysis for prenatal ultrasound exams, enhancing the detection of congenital heart defects and ensuring exam completeness.

Reviews & Opinions

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Press & Coverage

Medical Product Outsourcing
BrightHeart Secures European CE Mark for B-Right AI Prenatal Ultrasound Platform
BrightHeart has received CE Mark for its B-Right AI Platform, allowing commercialization across the EU. This follows an u20ac11 million Series A funding round and a partnership with GE HealthCare's Volusonu2122 Solution Store.
2026-06
Femtech Insider
BrightHeart Receives CE Mark for AI-Powered Prenatal Ultrasound Platform
BrightHeart's B-Right AI platform has received CE Mark approval, enabling its integration into routine prenatal care throughout the European Union. The platform aims to improve the detection of congenital anomalies, which often vary based on operator experience.
2026-06
Medical Device Network
BrightHeart raises u20ac11m to drive AI heart defect detection platform adoption
BrightHeart secured u20ac11 million in Series A funding to accelerate the commercialization of its AI-based prenatal congenital heart defect (CHD) screening platform, B-Right. The platform received FDA clearance in November 2024.
2026-01
AuntMinnie.com
BrightHeart closes on $12.8M funding round - AuntMinnie
BrightHeart has closed an u20ac11 million ($12.8 million) Series A financing round to support U.S. commercialization, European expansion, and product innovation for its B-Right AI platform, which aids in prenatal ultrasound screening for congenital defects.
2026-01
Tech.eu
BrightHeart bags u20ac11M to expand FDA-cleared AI ultrasound platform across the US and Europe - Tech.eu
BrightHeart has raised u20ac11 million in Series A financing to expand its FDA-cleared AI ultrasound platform across the US and Europe. The platform is designed to improve fetal heart screening and overall exam completeness.
2026-01
brightheart.ai
BrightHeart Announces CE Mark and European Launch of its AI Platform for Prenatal Ultrasound
BrightHeart announced it has received the CE mark for its medical devices, enabling the commercialization of its B-Right AI Platform across the European Union. The company will debut its platform at the Fetal Medicine Foundation (FMF) World Congress in Vienna.
2026-07
Sofinnova Partners
BrightHeart Sets New Standard in Prenatal CHD Screening with Landmark Study Published in Obstetrics & Gynecology
BrightHeart published a landmark study in Obstetrics & Gynecology, confirming its AI software as a transformative tool for prenatal screening of congenital heart defects (CHDs). The study showed 98.7% sensitivity in detecting severe CHDs.
2025-09
MedTech Dive
BrightHeart's AI software boosts prenatal heart defect detection by over 15%: study
Two studies presented at the SMFM 2025 Pregnancy Meeting demonstrated that BrightHeart's FDA-cleared AI software improved the diagnostic rate of congenital heart defects during prenatal ultrasounds, with one study showing a 15.3% increase in detection sensitivity.
2025-01

Frequently Asked Questions

BrightHeart's AI platform, including B-Right Screen AI, analyzes fetal ultrasound images in real-time to identify structural abnormalities and guide clinicians to capture necessary views, aiming to standardize screening and improve CHD detection rates. Studies have shown it can improve detection rates of suspicious findings for major CHDs to over 97%.
BrightHeart's B-Right AI Platform is designed for seamless integration with existing PACS systems and ultrasound machines, including availability through GE HealthCare's Volusonu2122 Solution Store. It provides real-time decision support without disrupting current clinical routines, aiming to optimize workflow efficiency and improve exam completeness.
BrightHeart has received multiple FDA 510(k) clearances for its B-Right AI platform and tools, including B-Right Screen AI and B-Right Views, and has approval for a Predetermined Change Control Plan (PCCP). As a regulated medical device company, BrightHeart operates in compliance with stringent medical device regulations, which inherently include data protection standards.
BrightHeart's technology is supported by extensive clinical validation studies, including a landmark multi-center retrospective study published in *Obstetrics & Gynecology*. This study demonstrated high sensitivity (98.7%) and specificity (97.7%) in detecting severe CHDs using standard grayscale ultrasound clips.
BrightHeart's specific pricing model is not publicly disclosed due to competitive sensitivity. However, healthcare facilities can anticipate ROI through improved early detection rates, reduced need for costly late-stage interventions, optimized referral pathways, and increased throughput by saving time and improving exam quality.
BrightHeart emphasizes providing comprehensive training and support to ensure smooth adoption and optimal utilization of its solutions. The company's collaboration with partners like GE HealthCare for integration into platforms such as the Volusonu2122 Solution Store also indicates accessible channels for ongoing technical and clinical support.
Founded in 2020, BrightHeart has demonstrated stability by securing u20ac11 million in Series A funding in January 2026 and achieving multiple FDA clearances. Their long-term vision is to make expert-level fetal heart screening a routine standard of care, with plans to expand their AI portfolio beyond the heart to support the entire prenatal ultrasound exam.

Investors

Who's funded BrightHeart.

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