Clarius Mobile Health has received FDA clearance for its Clarius OB AI fetal biometric measurement tool, which aims to improve access to obstetrical prenatal monitoring and care, especially in resource-limited areas. The Clarius OB AI model, now available with the Clarius C3 HD3 wireless handheld ultrasound scanner in the United States and Canada, automates fetal biometry measurements to estimate fetal age, weight, and growth intervals.
The Clarius OB AI model stands out due to its state-of-the-art deep learning models, developed using over 30,000 de-identified fetal ultrasound images. This technology provides consistent and precise measurements, empowering new ultrasound users such as midwives and nurses to perform accurate fetal ultrasound measurements with ease and confidence.
Carolyn L. Gegor, an ARDMS certified midwife sonographer, shared her experience with the tool: “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. 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.”
The need for accessible prenatal ultrasound is critical, as two-thirds of women worldwide lack access to this essential service. Ultrasound imaging is the gold standard for monitoring fetal wellbeing, but its high cost, lack of portability, and the extensive training required have hindered its widespread use. Clarius aims to address these barriers by combining AI with affordable and specialized ultrasound technology.
“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.”
The OB AI tool is included with a Clarius membership. Once activated on the Clarius app, OB AI automatically highlights key fetal anatomy and places calipers to calculate measurements. These measurements appear on screen and can be seamlessly added to a patient’s electronic record. Clarius OB AI is the eighth AI model developed in-house and available with Clarius ultrasound scanners.
