AI-Powered Ultrasound Scanner Receives FDA Approval for Prenatal Care


  • Sonio Detect, the AI-powered scanner revolutionizes prenatal care with enhanced imaging and early detection of birth defects. 
  • Sonio Detect high accuracy in identifying prenatal syndromes ensures better health outcomes for both mothers and babies. 
  • The AI-powered Sonio Detect serves as a safety net by streamlining ultrasound exams and allowing more time for patient care.

Paris-based femtech company Sonio has achieved a significant milestone in prenatal care with its AI-powered ultrasound scanning technology, Sonio Detect, becoming the first product to receive FDA approval. Sonio Detect can revolutionize prenatal care by enhancing ultrasound images and aiding in the early identification of birth defects, ultimately leading to better health outcomes for mothers and babies.

A helping hand for maternity care professionals

Sonio Detect is a high-tech assistant for maternity care professionals by scanning ultrasound images and identifying warning signs that may indicate fetal health issues. During rigorous testing, the technology analyzed over 70,000 ultrasound images and demonstrated an impressive accuracy rate of 95% or higher, successfully identifying more than 300 potential prenatal syndromes and anomalies.

Overcoming limitations of traditional ultrasound scans

Traditional fetal ultrasounds often suffer from lower quality or incomplete images, leading to approximately half of all fetal anomalies being missed before birth. Sonio Detect addresses these limitations by automatically extracting images from ultrasound clips, ensuring complete, high-quality exams. This crucial feature ensures that healthcare professionals can detect anomalies earlier and provide timely treatments to improve pregnancy outcomes.

A versatile and inclusive tool for all pregnant women

Sonio Detect is compatible with any ultrasound technology, including those from GE, Samsung, and Caron. This versatility allows for implementing customizable protocols irrespective of patients’ BMI, age, ethnicity, or gestational age. The technology’s broad applicability makes it a valuable and inclusive tool for monitoring and caring for pregnant women worldwide, including those in underserved areas, such as rural or underinsured regions.

AI as a safety net for physicians

For physicians, Sonio Detect serves as a “safety net” by verifying the quality and completeness of ultrasound exams, eliminating the need for manual labeling and checklists. This feature empowers physicians to spend more time with patients and on scanning rather than being burdened with cumbersome manual tasks. The AI-powered tool enhances the efficiency of physicians’ work and enables them to focus on confirming diagnoses and providing appropriate treatments.

Supporting population health trends

Dr. Marie Ramas, family physician and regional medical director of Aledade Health in New Hampshire, highlights the potential of AI in finding population health trends, especially in high-risk populations. By quickly and efficiently identifying known causes and diseases, obstetrical ultrasounds assisted by AI can free up physicians’ time for diagnosis and treatment confirmation. However, Dr. Ramas emphasizes the importance of using diagnostic tools to support clinical suspicion and not replace medicine’s expertise and human aspect.

Towards transforming prenatal care

Sonio Detect’s FDA approval is a significant step toward its availability in the United States by early October. Initially targeting women’s health MSOs, private practices, community centers, and academic centers, the company aims to transform prenatal care by ensuring better health outcomes for mothers and babies. The company is also investigating insurance coverage to make the technology more accessible to a broader range of patients.

Striking a balance between AI and human expertise

While AI can significantly enhance prenatal care, Dr. Ramas cautions against solely relying on algorithms to guide treatment protocols without the supervision of a family physician and care team. She highlights the risk of potential blind spots in diagnoses based on the perspectives of the coders who create the algorithms. The human aspect of medicine, with its heart and empathy, remains irreplaceable and essential in patient care.

Sonio Detect’s FDA approval marks a groundbreaking advancement in prenatal care, offering maternity care professionals a powerful tool to improve fetal anomalies’ accuracy and early detection. By leveraging the capabilities of AI, Sonio Detect complements and enhances the expertise of healthcare professionals, ultimately aiming to ensure better health outcomes for pregnant women and their babies. As the technology becomes available in the U.S., its potential to positively impact prenatal care and transform the lives of expectant mothers and their children is both promising and exciting.

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Glory Kaburu

Written by Glory Kaburu

Glory is an extremely knowledgeable journalist proficient with AI tools and research. She is passionate about AI and has authored several articles on the subject. She keeps herself abreast of the latest developments in Artificial Intelligence, Machine Learning, and Deep Learning and writes about them regularly.