Clarius OB AI Fetal Biometric Measurement Tool Nets FDA Clearance

Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, has obtained 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.

Developed with state-of-the-art deep learning models leveraging more than 30,000 de-identified fetal ultrasound images, 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.

"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. "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."

Two-thirds of women worldwide lack access to prenatal ultrasound for monitoring wellbeing. 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 aims to broaden ultrasound access for midwives and nurses, to help improve maternal and fetal health outcomes.

"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.