[UniverCité] Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

We’re excited to announce that Huma is the first company in the world to be awarded EU MDR Class IIb certification for a disease-agnostic software as a medical device (SaMD) platform.

This certification is a game changer for Huma, the healthcare industry and patients.

Now their platform can accurately diagnose even high-acuity conditions using smarter, more personalized insights generated from a patient’s medical history, symptoms, digital biomarkers and current condition. They can support patients of all ages with any condition – including infants, pregnant women and those with critical illnesses.

Instead of spending years developing a regulated app at a cost of up to tens of millions of dollars, healthcare, medtech and pharma companies can configure Huma’s Class IIb-approved platform to their specific needs.

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