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FDA clears Clarius OB AI for handheld ultrasound

Press releases may be edited for formatting or style | June 25, 2024 Ultrasound
Vancouver, BC, June 25, 2024 – 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 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 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. Clarius OB AI is the 8th AI model developed in-house that is available with Clarius ultrasound scanners.

On July 23, Clarius is hosting a practical webinar designed specifically for midwives with midwifery expert and ultrasound educator Carolyn Gegor. The one-hour webinar will focus on the role of first trimester point–of–care ultrasound in early pregnancy care. Registration is open now for the free webinar.


About Clarius Mobile Health 
Clarius is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals in every specialty. With decades of experience in medical imaging, the team knows that great ultrasound imaging improves confidence and patient care. Today, AI-powered Clarius handheld wireless ultrasound scanners connect to iOS and Android devices, delivering high-resolution ultrasound images traditionally only available with bulkier, high-end systems at a fraction of the cost. Almost 4 million high-definition scans have been performed using Clarius wireless handheld scanners. Clarius scanners are available in over 90 countries worldwide. Learn more at www.clarius.com. 

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