University of South Wales

Llusern Scientific Achieves ISO 13485 Certification for Rapid UTI Diagnostic System

- Llusern Scientific has received ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform that delivers lab-accurate UTI results in approximately 30 minutes. - The portable device addresses the global burden of over 400 million annual UTI cases by enabling precise bacterial identification and reducing antibiotic overprescription by up to two times. - The certification represents a crucial regulatory milestone for global market expansion, with commercial launches planned for India and MENA region in 2025 and the US in 2026.