Clarius Mobile Health has secured approval from the US Food and Drug Administration (FDA) for its Clarius OB AI foetal biometric measurement tool for handheld ultrasound.

Developed with deep learning models using more than 30,000 de-identified foetal ultrasound images, the tool is intended to enhance access to obstetrical (OB) prenatal monitoring, as well as care in resource-limited areas.

The OB AI model can automatically estimate foetal weight, age, and growth intervals. It is now available with the Clarius C3 HD3 wireless handheld ultrasound scanner in Canada and the US.

Capable of providing consistent and precise measurements, the Clarius OB AI allows new ultrasound users, including nurses and midwives, to conduct foetal ultrasound exams accurately.

The solution highlights key foetal anatomy after it is activated on the Clarius app when a clinician scans the abdomen.

It also places callipers for calculating measurements and displays them on the screen. These measurements can be easily added to the electronic record of a patient from the app.

Clarius president and CEO Ohad Arazi said: “OB AI is a testament to Clarius' commitment to innovation in the handheld ultrasound market.

“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 foetal health outcomes.”

Earlier this year, Clarius Mobile Health secured the FDA 510(k) clearance for its Clarius Bladder AI non-invasive tool designed to measure bladder volume.

Intended to provide real-time feedback to clinicians, the tool is designed to serve as a cost-effective alternative to traditional bladder scanners.