AI software receives FDA clearance to identify prenatal syndromes, anomalies

Key takeaways:

• Sonio Detect uses artificial intelligence to identify prenatal syndromes and abnormalities through ultrasound.
• The software has high sensitivity, specificity and accuracy across various patient subgroups.

The FDA granted 510(k) clearance in August to Sonio’s artificial intelligence-powered software that identifies hundreds of potential prenatal syndromes and anomalies through routine fetal ultrasound examinations, according to a press release.

Sonio Detect is AI-powered software that helps sonographers, OB/GYNs, maternal-fetal medicine specialists and fetal surgeons to perform routine fetal ultrasound examinations in real time. The software uses deep learning networks to automatically detect and label views, detect anatomical structures within supported views, and verify quality criteria of supported views through checking whether they conform to standardized criteria, according to a company press release.

“This achievement is a result of our team’s hard work and determination,” Cécile Brosset, CEO of Sonio, said in the release. “This accomplishment also reaffirms our commitment to give access to high-quality prenatal care to people all around the world.”

Th e software is one of few AI solutions for ultrasound practitioners , according to the release. Sonio Detect can be integrated with various ultrasound manufacturers and is verified to have high sensitivity and specificity while maintaining accuracy across various subgroups of women regardless of BMI, maternal age and ethnicity.

“This milestone marks just the beginning of an exciting journey. Sonio Detect’s FDA clearance propels us into a future where technology and medicine converge to reshape health care,” Rémi Besson, chief scientific officer of Sonio, said in the release. “The possibilities are limitless, and this achievement reinforces our dedication to the path ahead.”