The past couple of days have seen a handful of artificial intelligence algorithms for radiology imaging analysis receive 510(k) clearances from the FDA. Two of these, from Quantib and Ezra, are focused on the relatively untouched area of prostate cancer screening, while a third, from Aidoc, targets incidental pulmonary embolism.

Quantib's software delivers an in-workflow assessment of prostate imaging. The Dutch company's product is a collection of different tools designed to support diagnoses, such as calculations of prostate-specific antigen and a heat map that highlights those parts of an image that warrant radiologist review.

“Quantib’s FDA clearance is a game-changer for American radiologists who will, for the first time, have the powerful AI solutions they’ve been eager to implement for one of their most common disease areas,” Arthur Post Uiterweer, CEO of Quantib, said in a statement. “Both the instant impact and potential of this solution are significant for radiologists and patients alike. We aim to magnify that impact by focusing on widespread adoption and routine upgrades.”

The company also noted in the clearance announcement that it's planning to deploy the new software in 10 facilities during 2020, and is working on updates that to the product the will become available "over the coming months."

Ezra, meanwhile, touts the ability of its newly-cleared AI to accurately measure prostate volume, measure and grade the size of an identified prostate lesion, and – in the case of a biopsy – segment and represent the 3D volume of a prostate or lesion. Clinicians can access these tools through a web browser via the company's cloud-based Plexo platform.

"Over the past two years, our team has worked tirelessly on building Ezra's Prostate AI and I'm thrilled to bring it to our imaging partners across the US," Emi Gal, CEO and cofounder of Ezra, said in a statement. "We will continue to work towards making the interpretation of prostate MRI scans faster and more affordable, in order to support the millions of men who are at risk of prostate cancer."

And as for Aidoc, the FDA cleared its AI tool for the triaging and notification of incidental pulmonary embolism. The Israeli company's algorithm acts as an always-on catch net for hard-to-spot cases. According to Aidoc, its performance is unique due to the low incidence of incidental pulmonary embolism cases, and the wide breadth of imaging radiologists use.

"There's a reason why most AI triage solutions don't focus on incidental findings," Michael Braginsky, CTO of Aidoc, said in a statement. "Because the prevalence of incidental findings is relatively low, the specificity of the AI must be especially high, otherwise the false positive rate will be excessive and user adoption will be negatively impacted. In addition, an incidental [pulmonary embolism] algorithm detects [pulmonary embolism] in non-dedicated exams, where contrast is by definition suboptimal, and there’s an extremely high variability of protocols which challenges the AI even further."

WHAT'S THE IMPACT?

Prostate cancer is one of the most common cancers for men, with 13 in 100 developing the condition at some point in their lifetime, according to the CDC. And although an increasing number of algorithms are receiving the green light to assist radiologists with imaging interpretation, Quantib and Ezra both noted in their announcements that there's so far been little support in the area of prostate cancer. Like other automated imaging-analysis tools, these products work within the radiologist's workflow to help identify a case and characterize its imaging.

Aidoc's new product adds to the library of lung imaging analysis tools, but its focus on incidental pulmonary embolism allows teams to catch critical cases they may not have suspected. This allows care teams to begin intervention earlier, and potentially before an outpatient is sent home from the hospital.

THE LARGER TREND

More and more analysis algorithms are racking up regulatory clearances, with Aidoc and Quantib noted that these products mark their sixth cleared analysis algorithms.

The former company, for instance, had already received a clearance for pulmonary embolism (rather than incidental pulmonary embolism) in May of last year, and very shortly after picked up a 510(k) for a cervical spine fracture triage tool. Quantib's prior products include those for neurodegeneration and breast cancer, while Ezra's has built a full-body MRI scan that screens for cancer in up to 14 organs (and raised $18 million in Series A funding just a few months ago).

Other startups active in the space include Zebra Medical Vision and Paige.