New York, USA - (June 4, 2024) - Sonio, the artificial intelligence company revolutionizing fetal ultrasound reporting, announced today that the second version of their AI product, Sonio Detect, has officially been FDA cleared.

Sonio Detect AI is designed to ensure high-quality exams, automatically detecting views, anatomical structures, and verifying quality criteria of ultrasound images.

The latest version of Sonio Detect poses several new capabilities:

- A reliable ability to recognize fetal ultrasound views: it detects T1 views with 91,4% sensitivity and T2/T3 views with 93,7% sensitivity.

- Enables automatic extraction of complex views (heart/brain) from clips to reduce complexity and tediousness for sonographers: up to 10 min saved on complex exams*.

- 60 % of ISUOG and 63% of AIUM detailed exam protocols possible without manual annotation, with a roadmap set to cover 100% by next release.

- It detects brain structures with 93,4% sensitivity and 94,9% specificity as well as heart and thorax structures with 91,9% sensitivity and 97,6% specificity in the second and third trimester**. Sonio also automatically detects structures of placenta and CRL/NT and automatically detects placenta location and fetus sex, (see details in 510 K summary)

The value of the Sonio solution lies in the combination of modern, state-of-the-art IT infrastructure technology, backed by AI-enhanced clinical outcomes, to streamline workflows and bring efficiencies for healthcare professionals.

Sonio ultrasound reporting solution implements the latest IT infrastructure technologies and adheres to stringent security standards, such as HIPAA compliance and encryption protocols, to safeguard sensitive medical information and mitigate the risk of data breaches. It also enables OB GYN professionals to review, in a secure manner, images and reports remotely. This flexibility not only enhances clinical efficiency but also empowers practitioners to provide timely consultations and second opinions.

Sonio Cloud reporting software continually & seamlessly updates and improves the platform to incorporate the latest advancements in imaging technology, AI algorithms, and clinical decision support systems.

“We’re excited to reach this new milestone in Sonio’s launch in the US Market,” says Cecile Brosset, 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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