FDA Clears Updated Version of Sonio Detect Fetal Ultrasound Device
The second version of the device reportedly detects T2/T3 fetal ultrasound views with 93.7 percent sensitivity and enables 63 percent of AIUM exam protocols without manual annotation.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the second version of the Sonio Detect fetal ultrasound device.
The updated Sonio Detect provides a 91.4 percent sensitivity for T1 fetal ultrasound views and a 93.7 percent sensitivity for T2 and T3 views, according to Sonio, the developer of Sonio Detect.
The company said other key benefits of the fetal ultrasound system include:
• 93.4 percent sensitivity and 94.9 percent specificity in detecting fetal brain structures in the second and third trimesters;
• 91.9 percent sensitivity and 97.6 percent specificity in detection of fetal heart structures in the second and third trimesters; and
• automated annotation for 63 percent of American Institute of Ultrasound in Medicine (AIUM) exam protocols.
“We’re excited to reach this new milestone in Sonio’s launch in the US Market,” says Cecile Brosset, the CEO of Sonio. “Alongside our adoption in multiple hospitals across the US this year, we are proud to continue successfully expanding within the US provider market with this additional clearance.”
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