Sonio Detect is a Software as a Service (SaaS) solution designed to assist healthcare professionals during fetal ultrasound examinations. This solution was developed by Sonio and received premarket notification from the FDA on 7/25/2023.
Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views, and verify the quality criteria of the views.
Similar devices: SonoLyst feature embedded in the GE Medical device Voluson SWIFT ultrasound machine. Compared to this embedded feature in GE’s ultrasound medical device, the Sonio Detect device is cloud-based and can work with any ultrasound machine.
Ref: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230365.pdf