FDA clears Clarius OB AI, a handheld ultrasound tool

Clarius Mobile Health secured FDA clearance for the Clarius OB AI fetal biometric measurement tool on June 25, 2024. According to the company’s press release, the device offers broader access to obstetrical (OB) prenatal monitoring and care in areas with limited imaging resources. Alongside the Clarius C3 HD3 wireless handheld ultrasound scanner, the Clarius OB AI tool can automatically measure fetal biometry, estimating fetal age, weight, and growth intervals.

"OB AI is a testament to Clarius' commitment to innovation in the handheld ultrasound market," said Clarius President and CEO Ohad Arazi in the press release. "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 tool offers multiple features, including real-time anatomy identification, automated caliper placement, and faster diagnoses, presented through a user-friendly interface assisted by artificial intelligence (AI).

The device was trained using over 30,000 de-identified fetal ultrasound images and uses an advanced algorithm to conduct real-time analysis.

“Clarius OB AI ensures timely and precise evaluations, making quality prenatal care more accessible and expanding the reach of ultrasound to remote and underserved communities,” says the Clarius Mobile Health website.

The company estimates that two-thirds of pregnant women globally do not have access to imaging that can monitor and track their pregnancy's progress. Multiple barriers, including equipment costs, a need for more portability, and the need for trained technicians, pose a challenge for ultrasound access.

The company anticipates that the AI integration offered through this technology will expand the affordability of ultrasound technology and assist midwives and nurses in making diagnostic conclusions, offering an easier way to analyze ultrasound images.

"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," added Carolyn L. Gegor, an ARDMS certified midwife sonographer, in the press release. "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."

As the maternal mortality crisis across the United States continues, access to portable and efficient imaging tools is increasingly vital.