BrightHeart

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BrightHeart's B-Right AI Platform is an FDA-cleared solution that helps clinicians detect congenital heart defects during routine prenatal ultrasound scans with expert-level accuracy.

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About

BrightHeart is a medical AI company offering the B-Right AI Platform — a suite of FDA-cleared Class II medical devices designed to transform prenatal ultrasound screening. The platform targets one of the most critical challenges in obstetric care: the high rate of missed congenital heart defects (CHDs), with up to 70% going undetected during pregnancy due to variability in scan acquisition and interpretation. The B-Right AI Platform empowers sonographers and clinicians with real-time AI guidance during fetal anatomy scans. It automatically analyzes DICOM images and cine clips, assesses full exam completeness live during ultrasound capture, and delivers detailed evaluations of fetal heart structures — flagging abnormal findings or confirming their absence. Key capabilities include AI sensitivity for detecting severe CHD indicators, reduced false-negative and false-positive errors, and significantly faster reading times. The platform integrates as a plug-and-play solution, displaying results on a cart-side tablet during the scan and linking findings directly into existing reporting software — all with zero disruption to current workflows. BrightHeart is designed for hospitals, imaging centers, and prenatal care practices that want to standardize exam quality and extend expert-level cardiac screening beyond specialized centers. It is compatible with all major ultrasound manufacturers and works alongside existing reporting systems, making it accessible regardless of facility resources or clinician expertise level.

Key Features

Real-Time CHD Detection: AI algorithms analyze fetal heart structures live during ultrasound capture, flagging findings suspicious for major congenital heart defects.
Exam Completeness Assessment: Provides live AI-driven completeness checks during the scan to reduce incomplete fetal heart exams and improve standardization.
Automated DICOM Image Analysis: Automatically processes DICOM image files and cine clips, delivering expert-level AI annotations of key views and findings.
Seamless Workflow Integration: Plug-and-play compatibility with major ultrasound manufacturers; results display on a cart-side tablet and link directly into reporting software.
Detailed Standalone Web Platform: A web-based interface provides comprehensive AI assessments that clinicians can review outside of the scan room for thorough evaluation.

Use Cases

Hospitals and imaging centers performing routine 20-week fetal anatomy scans seeking to standardize cardiac screening quality and reduce missed CHD diagnoses.
Maternal-fetal medicine practices looking to augment sonographer performance with real-time AI guidance during fetal echocardiography.
Community hospitals and under-resourced prenatal care settings that lack on-site pediatric cardiologists but want to deliver expert-level screening.
Academic medical centers conducting research on AI-assisted prenatal diagnostics and publishing outcomes on CHD detection accuracy.
Healthcare networks aiming to reduce liability and improve clinical documentation quality across distributed ultrasound imaging sites.

Pros

FDA-Cleared Medical Device: Both B-Right Views and B-Right Screen are FDA-cleared Class II devices, ensuring regulatory compliance and clinical credibility.
No Workflow Disruption: Integrates as a plug-and-play solution compatible with existing ultrasound equipment and reporting systems, requiring no infrastructure changes.
Clinically Validated Performance: Published studies in peer-reviewed journals (e.g., Obstetrics & Gynecology) demonstrate high AI sensitivity and specificity for CHD detection.
Democratizes Expert Care: Extends expert-level fetal cardiac screening to facilities lacking specialized cardiologists, improving equity in prenatal care access.

Cons

Highly Specialized Use Case: The platform is purpose-built for prenatal cardiac ultrasound screening and is not applicable to other imaging modalities or clinical domains.
Enterprise Pricing with No Public Rates: Pricing is not publicly disclosed; healthcare organizations must request a demo, which may create friction for smaller practices evaluating cost.
Hardware Dependency: Requires compatible ultrasound equipment and cart-side tablet setup, which may require hardware assessment before deployment.

Frequently Asked Questions

The B-Right AI Platform is BrightHeart's suite of FDA-cleared AI tools designed to assist clinicians in detecting congenital heart defects during routine prenatal ultrasound anatomy scans.

Yes. Both B-Right Views and B-Right Screen are FDA-cleared Class II medical devices. Refer to BrightHeart's product regulatory documentation for full details.

Yes. BrightHeart integrates as a plug-and-play solution compatible with major ultrasound manufacturers and existing reporting software, requiring no changes to the current clinical setup.

The AI analyzes fetal heart images in real time during the scan, providing completeness checks, flagging suspicious CHD indicators, and reducing both false-negative and false-positive interpretation errors.

BrightHeart is designed for sonographers, OB-GYN clinicians, maternal-fetal medicine specialists, and healthcare facilities performing routine prenatal anatomy scans who want to improve CHD detection rates.