Medical Innovation Exchange

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds



Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically detect views and quality criteria of ultrasound images.

In clinical testing, Sonio Detect’s software was found to have a high accuracy rate in identifying correct labels, views and quality criteria—regardless of manufacturers—as well as patient BMI, age, ethnicity and gestational age. Additionally, Sonio Detect was validated on over 17k ultrasound images, showing more than 92% sensitivity on its ability to detect labels and types of ultrasound images.

In real time, it automatically detects views, anatomical structures within supported views, and verifies quality criteria of the supported views, allowing healthcare professionals to quickly detect presence of heart and brain structures, and other important fetal imaging quality criteria.

“We are deeply committed to advancing the field of prenatal health through innovation at Sonio. Obtaining FDA clearance for our products demonstrates our dedication to safety and efficacy in the U.S. market. Our goal is to ensure everyone has access to top-quality prenatal care across the globe,” said Remi Besson, co-founder of Sonio.

Related Articles

  • FDA

    The agency’s intent is to decrease regulatory burden while promoting patient access to products.

  • FDA 510(k) Clearance and Third-Party Reimbursement

    Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a 510(k) product.

  • Apple logo

    The product can conduct electrocardiograms and measure the heart’s rhythms.

  • FDA Updates List of Recognized Standards

    The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.


Original post:

Post publish date:


Leave a Comment

Your email address will not be published. Required fields are marked *

Leave the field below empty!