Fetal EchoScan (v1.2)
Overview
BrightHeart’s Fetal EchoScan (v1.2) is a machine learning-based computer-assisted diagnosis (CADx) software device. It is intended as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams (18 to 24 weeks of gestational age). The software analyzes cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, and right ventricular outflow tract standard views. Fetal EchoScan aims to provide information useful in diagnosing potential morphological abnormalities suggestive of fetal congenital heart defects, which may help determine the need for additional exams. It does not replace the role of the physician or other diagnostic testing in the standard of care. The device is not intended for use in multiple pregnancies, cases of heterotaxy, and postnatal ultrasound exams.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Machine learning-based computer-assisted diagnosis (CADx)
- Analyzes fetal ultrasound video clips (4-chamber, LVOT, RVOT views)
- Identifies suspicious radiographic findings in the fetal heart
- Aids in detecting morphological abnormalities suggestive of congenital heart defects
- Provides concurrent reading assistance for interpreting physicians
- Seamless integration into existing ultrasound workflows
- Compatible with major ultrasound manufacturers and reporting solutions
- Automatic display on cart-side tablet during scan
- Results summarized and linked in reporting software
- Detailed assessments on standalone web platform
Use Cases
- Adjunct to second-trimester fetal anatomic ultrasound exams (18-24 weeks gestation)
- Assisting OB-GYN and Maternal-Fetal Medicine (MFM) physicians in interpreting fetal heart ultrasounds
- Identifying potential congenital heart defects (CHDs) in fetuses
- Supporting clinicians in determining the need for additional fetal cardiac evaluations
- Enhancing confidence in confirming normal fetal heart findings
What Physicians Need to Know
Fetal EchoScan (v1.2) is a valuable adjunct to the interpreting physician's assessment of second-trimester fetal heart ultrasound videos, not a replacement for comprehensive medical judgment. It is crucial to understand that the tool is validated for use with specific ultrasound devices (Fujifilm, GE, Philips, Samsung, and Toshiba) and is not intended for multiple pregnancies, cases of heterotaxy, or postnatal ultrasound exams. While the AI provides information on suspicious morphological abnormalities, the ultimate diagnosis and determination of the need for additional exams remain with the physician. The tool can significantly improve diagnostic accuracy and efficiency, especially in identifying potential congenital heart defects, and can help standardize assessments.
Fetal EchoScan (v1.2) is a cloud-based, standalone AI platform that integrates seamlessly into existing ultrasound workflows as a plug-and-play solution. It is compatible with major ultrasound manufacturers and existing reporting solutions, allowing for automatic display on a cart-side tablet during the scan. It processes fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, and right ventricular outflow tract standard views.
Details
| Category | Cardiology AI, OB/GYN AI, Radiology & Imaging AI |
| Pricing | Unknown — unknown |
| Deployment | Cloud-based (implied by integration with existing workflows and web platform) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated Fetal EchoScan (v1.2) has received FDA 510(k) clearance (K252294) as a Class II medical device. It is indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Maternal-Fetal Medicine, Radiology |
What the Web Says
Fetal EchoScan (v1.2) is an FDA-cleared AI-powered software designed to assist physicians in interpreting fetal ultrasound images for suspicious cardiac findings. It was cleared by the FDA on December 8, 2025, and is intended to be used with specific ultrasound vendors like Fujifilm, GE, Philips, Samsung, and Toshiba. Studies indicate that physician reviews aided by Fetal EchoScan are more accurate than unaided reviews, showing significant increases in both sensitivity and specificity for detecting suspicious radiographic findings.
Overall: PositiveStrengths
- Significantly increases accuracy of physician reviews in detecting suspicious fetal cardiac findings compared to unaided reviews.
- Demonstrates high sensitivity and specificity in detecting suspicious findings.
- Performance is consistent across various subgroups, including gestational age, mother's age, BMI, race, ultrasound machine make and model, image quality, reader specialty, and country of practice.
- Outputs are annotated DICOM files that can be displayed in a DICOM viewer and optionally on a validated third-party user interface.
- Validated with major ultrasound vendors (Fujifilm, GE, Philips, Samsung, and Toshiba).
- FDA-cleared, indicating it meets safety and effectiveness standards.
Limitations
- Only validated for use with specific ultrasound vendors (Fujifilm, GE, Philips, Samsung, and Toshiba).
- Pricing and deployment details are not publicly available.
- Not ideal for buyers who need public price benchmarks before vendor contact or confirmed deployment details before shortlisting.
- Limited information available from independent tech reviewers, G2, or Capterra at this time.
Based on reviews from: Physician Ai Tools, Radiology AI Tools Directory, accessdata.fda.gov, BEUDAMED
Last updated: 2026-07-28
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