Software company Proscia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital pathology solution, Concentriq AP-Dx.
The Philadelphia-based firm said the "milestone" clearance would help spur laboratories' and pathologists' efficiency and efforts in tackling challenges such as cancer diagnosis.
Concentriq AP-Dx is a solution for viewing, interpreting, managing, and sharing whole-slide images with high resolutions, and has been cleared for the purpose of primary diagnosis, Proscia announced.
The firm said that Concentriq AP-Dx was designed to be intuitive for pathologists to use in a range of clinical settings and aid real-time collaboration—for example, with image views and case reviews.
In support of its 510(k) clearance, Proscia announced that it had conducted a multisite clinical study at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners. In the study, diagnoses made on Concentriq AP-Dx were found to be “non-inferior to traditional glass slide reads.” Relative to ground truth data, the difference in major discordance rates for slides read digitally and for slides read using the microscope was -0.1%, Proscia said.
The company said pathologists have been under increased pressure and facing systemic challenges.
“This regulatory milestone reflects our tireless commitment to our mission of perfecting cancer diagnosis,” said David West, Proscia’s CEO. “With 510(k) clearance, we can help more laboratories improve the pathologist experience and better serve their patients,” he said.
Concentriq AP-Dx is cleared (K230839) for clinical use with the Hamamatsu NanoZoomer S360MD Slide scanner in the U.S.