Platomics

Executive Summary

Platomics is an Austrian regulatory technology company founded in 2018 that automates compliance processes for the in vitro diagnostics (IVD) sector. Its digital platform connects IVD manufacturers and clinical laboratories to accelerate regulatory approval under the EU's In Vitro Diagnostic Regulation (IVDR), which came into full effect in 2022. By streamlining the complex IVDR transition, Platomics helps companies reduce time-to-market for new diagnostic tests and ensures compliance with stricter requirements for clinical evidence, risk management, and post-market surveillance. The company addresses a critical bottleneck in the diagnostics industry, where many small and medium-sized manufacturers struggle with the regulatory burden, and large laboratories face costly delays. With the IVDR deadline pushing labs to certify thousands of existing tests, Platomics' platform offers a scalable solution that could become a standard tool for regulatory management in Europe. The company has not yet disclosed funding or revenue, but its niche focus and timing align well with market needs.

Upcoming Catalysts (preview)

• Q3 2026First major IVDR certification processed entirely via Platomics platform70% success
• Q4 2026Partnership with a top European diagnostic laboratory network50% success
• TBDExpansion into US FDA regulatory workflows30% success