Minze is pleased to announce today that it has completed a Medical Device listing of Minze Diary Pod, Homeflow and Hospiflow and a facility registration of Minze Health, with the U.S. Food and Drug Administration (FDA).
The facility registration and listing of Minze’s LUTS diagnostics and remote patient and treatment monitoring (RPM, RTM) as Class II devices (510(k) exempt) are the first regulatory requirements for marketing Minze’s urology solutions in the USA.
Soon, millions of US citizens with Lower Urinary Tract Symptoms (LUTS) can be easily diagnosed from the comfort of their own home or in the hospital.
