DEEPECHO

DEEPECHO is a cloud-based software as a medical device that uses machine learning to analyze fetal ultrasound images and detect standard biometry views (cephalic, abdominal, femoral). It assists qualified healthcare professionals by suggesting caliper placement and automatically computing fetal biometric measurements including head circumference, abdominal circumference, femur length, and biparietal diameter during the second and third trimester (14–41 weeks gestation) in pregnant patients aged 18 and older.

DEEPECHO is a standalone cloud-based platform accessible from various devices, whereas the predicate SonioDetect operates as edge software requiring server installation. Both use artificial intelligence and machine learning for automated view detection and report generation. DEEPECHO computes a full set of biometric measurements (FL, AC, BPD, HC, EFW, EGA) directly in reports, while SonioDetect does not compute any biometric measurements. DEEPECHO detects only three views (cephalic, abdominal, femoral), a subset of SonioDetect's broader view detection capabilities.

Not stated in this summary.

Both devices are intended for use by trained healthcare professionals to assist in fetal ultrasound image analysis using AI/machine learning algorithms, share the same regulatory classification (892.1550), and serve the same clinical application (fetal obstetrics). While DEEPECHO differs in deployment method (cloud-based vs. server-based) and provides automated biometric measurement computation that the predicate does not, these differences do not raise different safety or effectiveness questions because both deployment methods are standard in medical device software, and automated measurement computation is a predictable extension of AI-assisted view detection already established by the predicate.