Paige receives FDA De Novo clearance for AI to detect prostate most cancers

Paige, a digital pathology diagnostics firm, has acquired De Novo advertising and marketing authorization from the Meals and Drug Administration for its synthetic intelligence software program that helps detect prostate most cancers.

The Paige Prostate software program analyzes digitized biopsy slides and identifies areas that may very well be cancerous for the pathologist to assessment additional.

“The approval is a landmark achievement within the subject of digital pathology and demonstrates how sturdy our know-how is when confronted with the broad vary of pure variations in tissue slides encountered in day-to-day medical follow,” Dr. Leo Grady, CEO of Paige, mentioned in a press release.

“We’re grateful for everybody at Paige and our medical companions who’ve introduced this new technology of computational pathology merchandise to actuality.”

Authorization for Paige Prostate was based mostly on a medical research the place 16 pathologists examined 527 prostate biopsy slides. The software program improved the pathologists’ capacity to detect most cancers on particular person slide pictures by a median of seven.3% (from 89.5% to 96.8%).

Additional, pathologists utilizing Paige’s software program had a 70% discount in false-negative diagnoses and a 24% discount in false-positive diagnoses. Paige Prostate additionally helped increase nonspecialist pathologists’ diagnostic accuracy to the identical stage as prostate specialists who weren’t utilizing the software program.

After beforehand receiving a CE Mark for the usage of Paige Prostate in laboratories and hospitals within the European Financial Space, Switzerland and the U.Okay., the corporate is now providing the software program within the U.S.

As a De Novo authorization, the FDA’s motion creates a brand new regulatory classification, which means that different software program with the identical meant use as Paige Prostate might undergo FDA’s 510(okay) premarket course of.


Prostate most cancers is the second most typical sort of most cancers amongst males, leading to lifetime diagnoses in roughly one in eight males, in line with the American Most cancers Society. It estimates there might be practically 250,000 new circumstances of prostate most cancers this 12 months.

This type of most cancers will trigger dying in roughly one in each 41 males, making it the second main reason for most cancers dying in American males, behind solely lung most cancers, in line with the American Most cancers Society. About 34,000 persons are anticipated to die from prostate most cancers this 12 months.

However due to advances in screening and remedy, the survival charges of prostate most cancers are bettering. The American Most cancers Society says the five-year relative survival charge of prostate most cancers is 90%, relying on the stage.

Paige’s software program has the flexibility to enhance prostate most cancers diagnostics, which might then enhance affected person outcomes, in line with FDA officers.

“Pathologists look at biopsies of tissue suspected for ailments, similar to prostate most cancers, each day. Figuring out areas of concern on the biopsy picture will help pathologists make a prognosis that informs the suitable remedy,” Dr. Tim Stenzel, director of the FDA’s Workplace of In Vitro Diagnostics and Radiological Well being, mentioned in a press release.

“The authorization of this AI-based software program will help enhance the variety of recognized prostate biopsy samples with cancerous tissue, which might in the end save lives.”


Paige’s pathology software program first acquired FDA recognition in 2019, when it was granted Breakthrough Gadget designation. Along with the prostate most cancers platform, Paige additionally developed AI know-how to detect breast most cancers.

The corporate is closely backed by traders, most lately bringing in over $125 million in its Collection C elevate.

Digital pathology is a rising subject with the likes of Deep Lens, Proscia and PathAI additionally growing tech-powered instruments to assist prognosis.


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