DEEPECHO is a cloud-based AI software for fetal ultrasound image analysis. It helps trained healthcare professionals detect important fetal views in ultrasound scans and suggests caliper placement for accurate biometric measurements like head circumference and femur length. The software supports real-time image streaming and exam management to improve fetal assessment during pregnancy between 14 and 41 weeks, aiding clinicians to make informed decisions efficiently.
Intended Use
DEEPECHO is intended to analyze fetal ultrasound images and clips using machine learning techniques to detect standard biometry views and assist in measurement computation of fetal biometric parameters for patients aged 18 years or older between the 14th and 41st weeks of pregnancy.
Technology
DEEPECHO is a cloud-based standalone software as a medical device (SaMD) designed for trained healthcare professionals. It takes DICOM images or real-time ultrasound video streams as input, identifies predefined fetal ultrasound views (cephalic, abdominal, femoral), and suggests caliper placements to compute biometric measurements like head circumference, femur length, and estimated fetal weight. The software offers concurrent reading and measuring aid during image acquisition and interpretation.
Performance
DEEPECHO underwent extensive non-clinical performance testing using 397 subjects' ultrasound data from multiple sites. Its AI algorithms showed high accuracy in biometric measurement computations and view detection, with high sensitivities (86.9–98.2%) and specificities (94.8–97.4%) across different anatomical views. Subgroup analyses confirmed robustness across demographic and device variables, and results support safety and effectiveness comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/30/2024
8 months - 2
FDA Approval
5/23/2025
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.