Proscia's digital pathology software solution gets FDA approval

Proscia, a software startup, has received FDA clearance for its Concentriq AP-Dx, a digital pathology tool, for primary diagnosis in the United States.

The Food and Drug Administration (FDA) in the United States has granted Proscia, a prominent supplier of digital and computational pathology solutions, 510(k) clearance for Concentriq AP-Dx. The business stated that the digital pathology solution is cleared (K230839) for clinical use with the Hamamatsu NanoZoomer S360MD Slide scanner in the United States and that it is approved for use in primary diagnosis.

Concentriq AP-Dx from Proscia is a complete diagnostic software solution that lets pathologists see, interpret, and manage full slide pictures in a simple manner while also boosting their confidence and productivity. Additionally, it can expedite cooperation and increase access to knowledge. Large hospital systems and lone reference laboratories alike can use Concentriq AP-Dx in clinical settings of various sizes.

Proscia carried out a multi-site clinical trial at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners to support its 510(k) clearance. The research showed that diagnoses obtained using Concentriq AP-Dx are comparable to those obtained using conventional glass slide readings. One of the most compelling results of comparable publicly accessible research was the -0.1% difference in significant discordance rates between slides read digitally and slides examined under a microscope when compared to ground truth data.