2N8life launches home-based NPT medical device

Munich-based company 2N8life has launched the 2N8 system, which it claims is the first CE-compliant medical device designed for systematic and reproducible nocturnal penile tumescence (NPT) measurement in a home setting.

Developed following requests from chief physicians at the Urological Clinic Munich-Planegg, the device aims to provide objective data to distinguish between organic and psychogenic erectile dysfunction. Beyond urological diagnostics, the system is intended to serve as a predictor for heart attack risk by providing indicators for cardiovascular abnormalities.

The accompanying app includes progress tracking and evaluations of mental influence factors, with all data processed anonymously in compliance with GDPR. The manufacturer's quality management system has been confirmed under ISO 13485 by TÜV Nord, supporting continued production and distribution within the European Union.