Landrich Group Helps miDiagnostics Secure FDA 510(k) Clearance

The Landrich Group is proud to announce that miDiagnostics has received FDA 510(k) clearance for its HSV-1&2 Cerebrospinal Fluid (CSF) IVD Kit, and we are honored to contribute clinical, quality and regulatory expertise in support of this important milestone.

The miDiagnostics HSV-1&2 CSF Test addresses a critical need in the diagnosis of encephalitis and meningitis, conditions where time is essential for effective treatment. The test provides fast and accurate point-of-care results in under 30 minutes with ultra-high sensitivity — reducing the need for additional confirmatory testing and helping clinicians act faster.

Landrich Group played a key role in designing and managing the Usability Engineering and Clinical performance Evaluation studies and guiding the regulatory strategy and submission processes, which contributed to accomplishment of gaining market access in the U.S. The FDA’s decision validates not only the assay, cartridge, and instrument, but also the accompanying software and cybersecurity measures — underscoring the strength of the entire development, clinical, quality and regulatory team.

We extend our congratulations to the miDiagnostics team and esteemed collaborators:

• The Johns Hopkins University, with Dr. Heba Mostafa as Principal Investigator

• Hampshire Hospitals NHS Foundation Trust

• University of Liverpool

• TriCore Reference Laboratories

This achievement reflects the value of effective collaboration between technology innovators, clinical partners, and experienced regulatory consultants. We are exceptionally proud to be part of a thriving ecosystem that brings safe and effective healthcare products to the market.

If you’re developing a breakthrough product and need experienced clinical, quality, and regulatory support, Landrich Group is here to help. Contact us at admin@landrichgroup.com for a free consultation, let’s start the innovation journey together!