Proscia Receives FDA 510(k) Clearance For Concentriq AP-Dx
PHILADELPHIA, Feb. 12, 2024 /PRNewswire-PRWeb/ -- Proscia®, a leading provider of digital and computational pathology solutions, 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.
- PHILADELPHIA, Feb. 12, 2024 /PRNewswire-PRWeb/ -- Proscia® , a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq® AP-Dx*.
- 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 multi-site clinical study at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners.
- In addition to its 510(k) clearance, Proscia was the first company to achieve CE-IVDR certification to advance primary diagnosis in the European Union.