The U.S. Food and Drug Administration (FDA) has cleared Sonio’s latest prenatal ultrasound AI algorithm, Sonio Suspect.
The technology helps clinicians identify congenital malformations on ultrasound from as early as 11 weeks gestation. In a multicenter reader performance study that included 47 sites, Sonio Suspect improved anomaly detection from 69% to 91%, the company said. It will be integrated into the firm’s reporting and workflow platform, which already includes Sonio Detect, a quality assurance algorithm.