FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Paige Earns CE Mark for Prostate Cancer Detection Solution

Nov. 13, 2019

Paige has earned the CE Mark for the Paige Prostate, a first-in-class prostate cancer detection solution, along with the Paige Insight, its AI-based digital pathology viewer.

The vendor neutral products allow pathologists to view and collaborate on digitized slides from different sites and scanners. The Paige Prostate provides clinical grade accuracy, with equivalent performance in images taken with multiple scanners and on slides prepared at hundreds of institutions.

"Pathology practices around the world have begun to embrace digital pathology and can begin to realize the potential of the technology with real-time quality assurance, gains in productivity, and improved collaboration across sites, “ said Paige CEO Leo Grady.

View today's stories