Emerging Prenatal Ultrasound Device Gets FDA’s Breakthrough Device Designation

The Food and Drug Administration (FDA) has granted its breakthrough device designation to DeepEcho Blind Sweep Platform, a prenatal ultrasound that provides an array of automated measurements.

DeepEcho, the developer of the ultrasound modality, said simple protocol-based ultrasound sweeps with the DeepEcho Blind Sweep Platform enable software-driven assessment of B-mode ultrasound videos.

Emphasizing consistency with prenatal ultrasound evaluations, DeepEcho noted that the AI-powered software for the DeepEcho Blind Sweep Platform generates multiple automated measurements, including assessments of amniotic fluid, placental location, fetal heart rate, estimated fetal weight and gestational age.

"We are building tools that support clinicians, helping extend their reach, reduce variability in exams, and ensure that more patients can benefit from high-quality assessments, no matter where they are," said Saad Slimani, M.D., the chief medical officer and co-founder of DeepEcho.