Logo
RadAI Slice
Subscribe

Intended Use

The BrightHeart View Classifier device is intended to analyze fetal ultrasound images and video clips using machine learning techniques to automatically detect standard views during fetal heart scanning. It is used as an adjunct to the acquisition and interpretation of fetal anatomic ultrasound examinations at the second or third trimester of pregnancy performed with transabdominal probes.

Technology

BrightHeart View Classifier is a cloud-based AI software that uses trained neural networks to classify standard views in fetal 2D grayscale ultrasound images and video clips. It processes input from ultrasound machines from specific vendors and outputs annotated DICOM files with identified standard views, assisting trained healthcare professionals during fetal heart ultrasound examinations.

Performance

Performance was validated on 2290 images and video frames from 579 fetal ultrasound exams across multiple centers and demographics, showing high sensitivity (0.939) and specificity (0.984) in detecting standard fetal heart views. The testing data was independent from training data, ensuring unbiased evaluation. Performance consistency across ultrasound machine vendors and patient subgroups was also demonstrated.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/29/2024

    5 months
  • 2

    FDA Approval

    5/7/2025

Other devices from BrightHeart

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.