FDA Clears Clarius OB AI for Handheld Ultrasound for Prenatal Monitoring

June 27, 2024 — Clarius Mobile Health, which provides high-definition handheld ultrasound systems, has obtained U.S. Food and Drug Administration (FDA) clearance for the Clarius OB AI fetal biometric measurement tool, improving access to obstetrical (OB) prenatal monitoring and care in resource-limited areas. The OB AI model automatically performs fetal biometry measurements to estimate fetal age, weight and growth intervals and is available now with the Clarius C3 HD3 wireless handheld ultrasound scanner in the United States and Canada.

Revolutionizing Prenatal Ultrasound with Artificial Intelligence (AI)

“OB AI is a testament to Clarius' commitment to innovation in the handheld ultrasound market,” said Clarius President and CEO Ohad Arazi. “Our mission is to make high-quality ultrasound technology accessible and user-friendly, and with OB AI we’re pleased to be helping more clinicians provide accurate and efficient prenatal assessments, ultimately improving maternal and fetal health outcomes.”

OB AI is included with Clarius membership. Once activated on the Clarius app while a clinician is scanning the abdomen, OB AI automatically highlights key fetal anatomy and places calipers to calculate measurements, which appear on screen and can be added to a patient’s electronic record from the app.

Clarius OB AI is the company’s 8th AI model, designed to make ultrasound more accessible and user-friendly for every clinician, reports the company. Developed with state-of-the-art deep learning models and leveraging over 30,000 de-identified fetal ultrasound images, Clarius OB AI is now available with the Clarius C3 HD3 wireless handheld ultrasound scanner in the United States and Canada.

The company reports that the cutting-edge tool automates complex obstetric calculations during pregnancy, making it easier than ever for midwives and nurses to perform accurate fetal ultrasound exams. Clarius OB AI provides consistent and precise measurements enabling new ultrasound users, including midwives and nurses, the ability to perform accurate fetal ultrasound measurements with confidence. Additionally, the company reports, by automatically estimating fetal age, weight, and growth intervals, Clarius OB AI ensures consistent and precise measurements.

“When I used Clarius OB AI while teaching OB ultrasound to a group of midwives, I was impressed by the accuracy of cursor placement on multiple scans, from crown rump length to biparietal diameter and femur length,” says Carolyn L. Gegor, an ARDMS certified midwife sonographer. Gregor added, “I found that after using the OB AI model, the students were more able to properly measure structures without the assistance of the AI. It was a quality improvement and time saver for me as a skilled scanner and an excellent teaching modality for those without previous scanning experience.”

Enhancing Access to Quality Prenatal Care

Two-thirds of women worldwide lack access to prenatal ultrasound for monitoring wellbeing¹. While ultrasound imaging is widely recognized as the gold standard for capturing accurate biometric measurements to monitor fetal wellbeing, the high cost of equipment, lack of portability, and the extensive training required are barriers to widespread adoption by midwives and nurses. By integrating AI with affordable and specialized ultrasound technology, Clarius reports that it aims to broaden ultrasound access for midwives and nurses, to help improve maternal and fetal health outcomes.

For more information: www.clarius.com

Reference:

¹Mariani G, Kasznia-Brown J, Paez D, Mikhail MN, H Salama D, Bhatla N, Erba PA, Kashyap R. Improving women’s health in low-income and middle-income countries. Part II: the needs of diagnostic imaging. Nucl Med Commun. 2017 Dec;38(12):1024-1028. doi: 10.1097/MNM.0000000000000752. PMID: 28953209; PMCID: PMC5704652.