FDA Clears Ultrasound AI Module for Detection of Fetal Anomalies

The Food and Drug Administration (FDA) has granted 510(k) clearance for Sonio Suspect, an artificial intelligence (AI)-enabled module that reportedly facilitates enhanced ultrasound detection of fetal anomalies.

Approximately 51 percent of fetal anomalies are not detected during conventional prenatal ultrasound screenings, according to Sonio, the developer of the Sonio Suspect software. The company says Sonio Suspect provides automated detection of eight ultrasound findings of fetal abnormalities across the heart, brain, and abdomen.

In a recent 47-facility multicenter study, Sonio said the Sonio Suspect module achieved a 91 percent area under the receiver operating characteristic curve (AUC) for fetal anomaly detection, a 22 percent improvement over unassisted interpretation. The company said the improved detection with Sonio Suspect was consistent regardless of clinician experience or background.

“By combining real-time AI quality control with AI-driven anomaly detection, Sonio supports ultrasound providers from exhaustive documentation to accurate diagnosis,” noted Cecile Brosset, the CEO and co-founder at Sonio. “Our technology is designed to help health-care providers detect issues early and streamline processes, ultimately improving the care every patient receives.”