Clarius tacks on European nod for whole-body hand-held ultrasound scanner

Only a few months after unveiling its new dual-array hand-held ultrasound device—with FDA clearance already in hand—Clarius Mobile Health is venturing further afield.

The Canadian company has added a handful of regulatory clearances this month allowing the Clarius PAL HD3 scanner to be used on multiple continents.

First up, earlier this month, Clarius announced that the wireless device had been cleared for use in the EU and the U.K. Not even a week later, it debuted the PAL HD3 in Australia.

“With Clarius PAL, we set out to design a new class of whole-body ultrasound device that produces superior image quality for shallow and deep anatomy, which no other handheld devices including other Clarius scanners can match,” Kris Dickie, the company’s chief technology officer, said in the latter announcement. “The popularity of the Clarius PAL in the United States affirms there’s a strong market for a premium ultrasound scanner that supports whole-body exams and broad clinical applications for physicians in urban and rural hospitals and clinics.”

The smartphone-sized PAL device offers both phased and linear arrays in a single head. The low-frequency phased array can be used for deeper imaging of the heart, lungs and abdomen, reaching depths of up to 40 centimeters, while the high-frequency linear array can be used to scan a patient’s vasculature and other shallower imaging needs.

The device’s multi-use abilities and small footprint add up to significant cost savings, according to Clarius. The PAL HD3 starts at $5,395 for the scanner, plus another $595 per year for a membership with the company, which provides additional tech features, expanded image storage and access to virtual training materials.

“You can probably do 95 to 99% of all the ultrasound imaging you need to do during a shift with this single device,” Tom Cook, M.D., a South Carolina-based emergency physician, said in Clarius’ CE mark announcement. “If you compare the cost of this device to a cart-based system, you’re talking a factor of 10 to 15, maybe even 20, depending on the type of system you’re using. So, it’s very, very inexpensive.”

The portable system relies on artificial intelligence and its eight beamformers to churn out high-quality scans, which are then automatically sent to and stored in an accompanying smartphone app. From there, the images can be saved to a hospital’s existing digital storage system or to Clarius’ own cloud.

Also this month, Clarius earned yet another regulatory nod for a new feature that can be added to the PAL HD3 and two more of its hand-held ultrasound scanners. That FDA 510(k) clearance went to Clarius Bladder AI, which automatically measures bladder volume in real time during a scan.

The new AI feature is included in the Clarius membership, and it joins a handful of other AI-powered tools that can be added to the company’s scanners, including one cleared by the FDA last year that automatically spots and measures tendon structures in the foot, ankle and knee to aid in diagnosing and treating musculoskeletal injuries.