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Wire · opportunities

Proscia Receives New FDA 510(k) Clearance for Concentriq AP-Dx with Predetermined ...

6 August 2026 · By · Wire by Fusion42

Published

6 August 2026

Topic

opportunities

◆ Sectors

Digital Health

◆ Geography

United States

◆ Source

Read at biospace.com →

◆ Verified

Fusion42 · 30 August 2026 · Fusion42 review

Proscia received FDA 510(k) clearance for its Concentriq AP-Dx digital pathology platform with a Predetermined Change Control Plan allowing expanded interoperability without new submissions.

This Wire brief sits within Fusion42's coverage of Digital Health.

◆ ◆ The Wire takeaway

You now have a clearer path to integrate additional FDA-cleared scanners and formats into your digital pathology solutions without redoing regulatory filings. This reduces friction and speeds up expansion if you serve diagnostic labs or pharmaceutical clients.

◆ Coverage

1 source · 6 Aug 2026

◆ Related on Wire

◆ Topics

Digital Healthfda-clearancedigital-pathologyregulatory-approvalinteroperabilityhealthtech