We received FDA 510(k) clearance for our miDiagnostics HSV-1&2 Test.
The miDiagnostics HSV-1&2 Test addresses a critical need in the diagnosis of encephalitis and meningitis, conditions where speed is essential for effective treatment. It delivers fast and accurate results in under 30 minutes at the point of care with ultra-high sensitivity, reducing the need for additional confirmatory testing.
This is a major achievement, and we feel privileged to have such a dedicated and talented miDiagnostics team, whose expertise made this milestone possible, and to have partners like The Johns Hopkins University (US), where Heba Mostafa, MD, PhD, D(ABMM), FIDSA served as Principal Investigator, Hampshire Hospitals NHS Foundation Trust (UK), University of Liverpool (UK), and TriCore Reference Laboratories (US), whose collaboration and support were invaluable in our clinical trial.
The clearance covers the assay, cartridge, instrument, software, and cybersecurity/quality controls—a full system validation that confirms the robustness of our technology and the strength of our regulatory team.
