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Digital Pathology Solution Receives FDA 510(k) Clearance

Key regulatory milestone advances company’s mission to perfect cancer diagnosis

Proscia Inc.

Proscia is a software company that is accelerating pathology’s transformation toward a data-driven discipline.

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Published:Feb 12, 2024
|1 min read
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PHILADELPHIA — Proscia® has received 510(k) clearance from the U.S. FDA for its Concentriq® AP-Dx* for primary diagnosis purposes.

The Concentriq® AP-Dx is a comprehensive diagnostic software solution that immerses pathologists in an intuitive experience for viewing, interpreting, and managing whole-slide images and helps to drive confidence and efficiency gains. It can also streamline collaboration, broadening access to expertise. Concentriq® AP-Dx was designed to be used in clinical settings of all sizes, from individual reference laboratories to the largest hospital systems.

In support of its 510(k) clearance, Proscia conducted a multisite clinical study to demonstrate that diagnoses made on Concentriq® AP-Dx are noninferior 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 percent, one of the strongest findings of similar publicly available studies.

“This regulatory milestone reflects our tireless commitment to our mission of perfecting cancer diagnosis,” said David West, BS, Proscia’s CEO. “Pathologists are facing more pressure than ever before in the fight against some of humanity’s biggest challenges. With 510(k) clearance, we can help more laboratories improve the pathologist experience and better serve their patients.”

Up to 70 percent of clinical decisions depend on pathology. Digital pathology shifts the standard from microscope to high-resolution images, each containing over 1 billion pixels that tell the story of a patient’s disease and hold the keys to advancing precision medicine. It is also driving powerful efficiency gains that help laboratories overcome systemic challenges, like staffing and healthcare resource crises.

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

- This press release was originally published on the Proscia Inc. website