BrightHeart View Classifier
Overview
BrightHeart’s B-Right AI Platform empowers clinicians and sonographers by facilitating comprehensive and standardized expert-level assessments during routine anatomy scans. The platform addresses the variability and complexity of prenatal ultrasound assessments, which often result in inconsistent documentation, inefficient workflows, and missed congenital heart defects (CHDs).
The B-Right AI Platform, including its B-Right Views tool, enables expert-level care by supporting exam completeness and confident interpretation. B-Right Views automatically detects the standard views required for second and third-trimester fetal heart ultrasound evaluations within routine anatomy scans, confirming when all recommended views are captured and documented. The B-Right Screen AI software flags structural markers suggestive of CHDs to assist in their detection.
BrightHeart’s standalone AI platform integrates seamlessly into any existing workflow as a plug-and-play solution, compatible with major ultrasound manufacturers and existing reporting solutions. It offers real-time AI assessment and detailed evaluations of fetal heart structures, highlighting abnormal findings or confirming their absence, often displayed on a cart-side tablet during the scan.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered analysis of fetal heart ultrasound exams
- Real-time guidance during prenatal ultrasound exams via cart-side tablet
- Automatic detection and confirmation of standard fetal heart views (B-Right Views)
- Flags potential structural abnormalities suggestive of congenital heart defects (B-Right Screen AI)
- Ensures exam completeness and consistency regardless of operator experience
- Seamless integration into existing ultrasound workflows as a plug-and-play solution
- Compatible with major ultrasound manufacturers and existing reporting solutions
- Reduction in incomplete fetal heart scans and patient recall rates
- Supports confident clinical decision-making and interpretation
- Detailed AI evaluation of fetal heart structures with expert-level annotation
Use Cases
- Prenatal screening for congenital heart defects (CHDs)
- Standardizing fetal heart ultrasound examinations
- Improving detection rates of fetal cardiac anomalies in utero
- Optimizing workflow efficiency for sonographers and clinicians during ultrasound scans
- Providing decision support for OB-GYNs and maternal-fetal medicine specialists in complex anatomy assessment
- Reducing the need for repeat scans due to incomplete or inconsistent exams
What Physicians Need to Know
Leverage BrightHeart View Classifier to standardize fetal heart screening protocols, ensuring comprehensive view acquisition and documentation. Utilize the real-time feedback to immediately address any missing views, thereby improving exam completeness and reducing variability. The AI's ability to flag suspicious findings can aid in earlier identification of potential congenital heart defects, prompting timely specialist consultation and intervention planning. This tool can enhance confidence in confirming normal findings, providing reassurance to expectant families.
The BrightHeart AI platform is designed for seamless integration into existing ultrasound workflows. It is compatible with standard DICOM formats and major ultrasound manufacturers. The system allows for on-site pseudonymization, ensuring no Protected Health Information (PHI) is sent to the BrightHeart cloud. Device outputs are formatted as DICOM files, compatible with any DICOM viewer, and results are summarized and linked in existing reporting software, with detailed assessments available on a standalone web platform.
Details
| Category | Cardiology AI, OB/GYN AI |
| Pricing | Not disclosed publicly. — N/A |
| Deployment | Cloud-based solution, integrates seamlessly into existing ultrasound workflows as a plug-and-play solution. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated BrightHeart has received multiple FDA 510(k) clearances for its B-Right AI Platform. This includes an initial clearance for B-Right Screen AI software in November 2024, a platform expansion for real-time tablet access in May 2025, and a clearance for B-Right Views on May 14, 2025. The K251456 clearance for Radiology is noted as 06/05/2025. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Maternal-Fetal Medicine, Obstetrics & Gynecology |
What the Web Says
BrightHeart View Classifier is an AI-powered, FDA-cleared software designed to enhance prenatal ultrasound exams for detecting congenital heart defects (CHDs) and ensuring exam completeness. It provides real-time guidance via a cart-side tablet, integrating seamlessly into existing ultrasound workflows. The platform aims to standardize screening quality and improve early detection rates of CHDs, which are often missed in routine prenatal screenings.
Overall: PositiveStrengths
- Real-time AI guidance during prenatal ultrasound exams.
- Enhances accuracy and completeness of fetal heart scans, regardless of operator experience.
- High sensitivity (98.7%) and specificity (97.7%) for detecting severe CHDs.
- Seamless plug-and-play integration with existing ultrasound workflows and major manufacturers (GE HealthCare, Philips, Samsung, Siemens).
- Reduces incomplete fetal heart scans by 47% and reading times for specialists by 18%.
- FDA cleared with a Predetermined Change Control Plan (PCCP) for efficient future enhancements.
Limitations
- Pricing is not publicly disclosed.
- Public information does not explicitly state HIPAA compliance or BAA availability, which is a key consideration for enterprise adoption.
- Validated only with specific ultrasound vendors (General Electric, Philips, Samsung, and Siemens).
- No ratings or reviews found on G2 or Capterra.
- Limited information on Reddit, primarily unrelated to the medical device.
- Clinical trial results for some comparisons show other tools with more concrete, quantifiable reductions in misses for specific conditions.
Based on reviews from: Medical AI Tools for Physicians (Vertex AI Search), BrightHeart AI, FDA.gov, GE HealthCare, DAIC (Diagnostic and Interventional Cardiology), Sofinnova Partners, Obstetrics & Gynecology (Journal), Meta AI, Reddit
Last updated: 2026-07-17
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Press & Coverage
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