New AI ultrasound tech is first to land FDA approval to enhance prenatal care: ‘Better health outcomes'

Artificial intelligence-powered ultrasounds are now one step closer to becoming part of routine prenatal care.

Sonio Detect, an AI-powered ultrasound scanning technology, has become the first product of its kind to land FDA approval.

Made by Sonio, a "femtech" company based in Paris, France, the AI product functions as a high-tech helper for maternity care professionals, scanning for warning signs that could indicate fetal health issues.

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During testing, when Sonio Detect scanned over 70,000 ultrasound images, the technology identified more than 300 potential prenatal syndromes and anomalies with an accuracy rate of 95% or higher, the company said.

Sonio Detect is compatible with any type of ultrasound technology, including GE, Samsung and Caron, according to a press release announcing the FDA approval.

An AI-powered ultrasound scanning technology called Sonio Detect has become the first product of its kind to land FDA approval. (Sonio)

"Traditional fetal ultrasounds require manual labeling on every captured image," Sonio’s CEO and co-founder Cecile Brosset said in an interview with Fox News Digital. 

"This manual process is prone to errors and forgetting important images of the fetus — especially when a standard second-trimester exam includes more than 80 images."

Studies show that ultrasound exams are often lower in quality or incomplete, leading to half of all fetal anomalies being missed before birth, Brosset said.

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Birth defects affect one in every 33 babies born in the United States each year, according to the Centers for Disease Control and Prevention (CDC). 

About half are not detected during ultrasounds.

The AI product functions as a high-tech helper for maternity care professionals, scanning for warning signs that could indicate fetal health issues. (Sonio)

"Missing a fetal view or taking a low-quality image can lead to missed anomalies that could have been detected earlier," Brosset said. 

"This leads to a lack of proper care of pregnant women and fetuses when treatments could have drastically improved the pregnancy outcome."

"Missing a fetal view or taking a low-quality image can lead to missed anomalies that could have been detected earlier."

Sonio Detect helps health care professionals ensure that ultrasound exams are complete and that the images are of good quality. It also has the capability to automatically extract images from clips acquired by physicians. 

For physicians, Brosset said, the AI-powered tool serves as a "safety net," giving them peace of mind by verifying the quality and exhaustiveness of their exams.

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"They are not bothered with manual labeling or checklists, which means they get to spend more time with the patient and on scanning rather than cumbersome manual tasks," she said.

Sonio Detect is designed for use by all pregnant women, not just high-risk patients, Brosset noted.

During testing, when Sonio Detect scanned over 70,000 ultrasound images, the technology identified more than 300 potential prenatal syndromes and anomalies with an accuracy rate of 95% or higher, the company said. (Sonio)

"The technology ensures that complete customizable protocols can be implemented regardless of patients' BMI, age, ethnicity or gestational age," she said. 

"This broad applicability makes it a valuable and inclusive tool for monitoring and caring for" pregnant women all over the world, she also said. 

Dr. Marie Ramas, family physician and regional medical director of Aledade Health in New Hampshire, said she can foresee the Sonio Direct tool being very helpful in underserved areas, such as rural or underinsured regions. 

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"Due to a current health care environment that looks more and more at population health and creates pathways that reinforce practices and procedures to normalize outcomes, I can see a place for AI to help move us into that direction," she told Fox News Digital.

"The algorithms of AI could be useful in finding population health trends, especially in high-risk populations," she went on. 

"Obstetrical ultrasounds can identify known causes and diseases quickly and efficiently. This can free up a physician’s time to confirm a diagnosis and treatment."

Sonio Detect is designed to assist the sonographer and ultrasound reader to make the best decision, but is not intended to replace their expertise. (Sonio)

Sonio Detect is designed to assist the sonographer and ultrasound reader to make the best decision — but is not intended to replace their expertise.

"Diagnostic tools should be used to support clinical suspicion," said Ramas. "With the physician workforce declining and non-physician clinical care increasing, we have to be careful about using algorithms to guide treatment protocols outside of a family physician and care team."

"The use of AI cannot replace the heart and human aspect of medicine."

"The use of AI cannot replace the heart and human aspect of medicine," she went on. 

"The development of algorithms is still based on the perceived perspectives of the coders who create them, leading to potential blind spots in diagnoses."

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Now that the company has received FDA approval, the goal is to make Sonio Detect available in the U.S. by early October.

It will be available initially to women’s health MSOs (management services organizations), private practices, community centers and academic centers. 

The company is still investigating insurance coverage.

Said Brosset, "Our goal is to transform prenatal care by providing a reliable tool that ensures better health outcomes for both mothers and babies."

Melissa Rudy is health editor and a member of the lifestyle team at Fox News Digital.