Development statusAll three device programs (Spira, Neura, Pharyna) are pre-clinical. No MSTFA instrument is FDA cleared, CE marked, or available for clinical use. Nothing on this website is medical advice.
PathwayFDA 510(k) for each device program; predicate analysis per program. Plexus is data infrastructure, not a regulated device.
Quality managementISO 13485 quality management planned for manufacture; ISO 10993 biocompatibility for skin-contact components.
Data handlingPlexus is designed HIPAA-oriented: audit logging on every access, append-only raw retention, patient-controlled export.