PHILADELPHIA, PA — Proscia received a new U.S. Food and Drug Administration 510(k) clearance for its Concentriq AP-Dx digital pathology platform, expanding scanner compatibility and giving the company a regulatory pathway to add certain future technologies without filing a new 510(k) submission each time.
The clearance covers compatibility with Leica’s Aperio GT 450 DX slide scanner, cloud deployment and a Predetermined Change Control Plan, or PCCP.
Under the PCCP, Proscia can validate and implement support for additional FDA-cleared scanners, image formats and displays without submitting a separate 510(k) application for each change, while remaining subject to FDA oversight.
The provision could reduce regulatory friction as laboratories add or replace digital pathology equipment and seek to avoid dependence on a single proprietary technology ecosystem.
“Laboratories choose a digital pathology platform with the expectation that it will sit at the center of their practice for years to come,” Ian Cadieux, Proscia’s head of quality and regulatory, said. He said the PCCP is intended to preserve interoperability as laboratory technology requirements change.
Concentriq AP-Dx is used for primary diagnosis in digital pathology. The platform first received FDA 510(k) clearance in February 2024 for use with Hamamatsu’s NanoZoomer S360MD Slide scanner.
The latest clearance broadens that regulatory footprint as laboratories face rising diagnostic demand. Proscia cited projections that more than 2.1 million Americans will be diagnosed with cancer this year and pointed to a declining pathologist workforce as a driver of digital adoption.
The company also cited KLAS Research’s 2026 Digital Pathology report, which ranked Proscia highest for supporting customer integration goals and for overall performance based on customer feedback.
Proscia said its technology is used by diagnostic laboratories handling 12 million patient cases annually and by 16 of the world’s 20 largest pharmaceutical companies.
Concentriq AP-Dx is also CE-marked under the European Union’s In Vitro Diagnostic Regulation.
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