Proscia receives FDA 510(k) clearance for Concentriq AP-Dx

Feb. 14, 2024
Key regulatory milestone advances company’s mission.

Proscia has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq AP-Dx. The digital pathology solution was cleared for the purpose of primary diagnosis.

In support of its 510(k) clearance, Proscia conducted a multi-site clinical study at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners. The study demonstrated that diagnoses made on Concentriq AP-Dx are 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%.

To learn more about Concentriq AP-Dx and see a live demo, register for Proscia’s webinar. “Welcome to Concentriq AP-Dx” will take place on Friday, March 8 at 12PM EST.

*Concentriq AP-Dx is cleared (K230839) for clinical use with the Hamamatsu NanoZoomer S360MD Slide scanner in the United States.

Proscia release