FDA approves AI ultrasound application for musculoskeletal imaging

Clarius Mobile Health, which first introduced wireless handheld imaging for medical specialties in 2016, says its third-generation device, HD3, which was approved by the U.S. Food and Drug Administration this week, will also help improve MSK ultrasound training.

Why it matters
With clearance from the FDA, the new MSK AI model will be available with the Clarius L7 HD3 and Clarius L15 HD3 ultrasound scanners introduced last year, according to the announcement.

“AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound,” said Ohad Arazi, president and CEO. in the statement.

Upon MSK imaging for specific anatomical sites, – the plantar fascia, or foot, Achilles tendon, or ankle and patellar tendon, or knee – the AI program analyzes and displays a transparent color overlay identifying the tendon.

Clinicians can then pause the image, and the device uses AI to label the tendon and determine the greatest thickness, automatically placing measurement calipers that correspond to the top and bottom of the tendon at its thickest region.

Users can also alter the measurement calipers “to make any necessary adjustments to support clinical decision-making,” the company says.

The company notes that ultrasound imaging has reached a new level of “affordability and usability,” with costs on its website advertised at about half of what the list price was in 2016 when it received 510(k) clearance for its app-based wireless ultrasound scanners.

One early tester, orthopedic surgeon Dr Alan Hirahara, commented on how the addition of AI will help educate new users of handheld orthopedic scanning.

“The technology will also help current users standardize how structures are measured,” he said in the announcement. “In research, interobserver variability exists for any measurement of structures. With the AI standardization of measurements, interobserver reliability problems will now be non-existent.”

The larger trend
Ultrasounds are a critical tool in myriad healthcare practices. They are so ubiquitous that Covid-19-era staffing shortages that are still prevalent in healthcare are affecting appointment availability volumes, and could be a contributing factor exacerbating health inequity.

With point-of-care ultrasound (POCUS) devices, clinicians can ultrasound right in the exam room and increase the speed of care as they serve more patients and get them through ultrasound booking bottlenecks.

“The newer devices are portable, affordable, durable, and through the support of AI and software are highly usable in addition to being easily integrated within existing clinical systems and workflows,” according to Dr John Martin, chief medical officer at Butterfly Network, another ultrasound platform vendor.

Dr Mark Favot, associate professor and director of EM Ultrasound Education at the Wayne State University School of Medicine in Detroit, also spoke with us last year about how AI can elevate the efficacy of POCUS devices to improve care access and reduce healthcare costs.

“Artificial intelligence has the potential to dramatically increase the effectiveness of POCUS, primarily by reducing the impact of poor confidence in image interpretation, which is one of the most common barriers to POCUS implementation,” he said.

On the record
“AI isn’t here to replace the ultimate decision by a clinician and it’s commendable that the FDA recognizes the value of AI for optimizing ultrasound image acquisition,” Arazi said in the announcement.

“If you’ve ever had an ultrasound image taken, you know it takes a very high degree of proficiency. What’s really exciting about AI and ultrasound is that it’s now enabling less proficient healthcare practitioners to acquire quality images to make meaningful clinical decisions quickly.” Healthcare IT News