Digital health company, Huma Therapeutics has become the only company in the world to receive EU MDR 2017/745 Class IIb certification for a disease agnostic Software as a Medical Device (SaMD).
Huma provides a ready-to-use platform that enables other companies to reduce the time and cost to bring SaMD products to market. The certification means the SaMD platform can monitor patients of all ages with any conditions, including infants and in pregnancy, as well as connecting to a wide range of external devices such as heart rate or blood sugar monitors. In addition to self-monitoring by patients, the platform supports clinicians to manage serious or critical health conditions such as heart failure and cancer, among others.
Clinical evidence from over 20 peer-reviewed publications and studies were submitted for regulatory assessment of clinical safety and efficacy to obtain the certification.
Dan Vahdat, CEO & Founder of Huma, said: “We have spent more than a decade advancing our platform and we are delighted to see this validated by achieving Class IIb certification which is a breakthrough for the entire digital health industry. Now, instead of spending years developing a regulated app at a cost sometimes running into tens of millions of dollars, companies can configure our Class IIb-approved platform to their specific needs, thus reducing risk and democratising innovation in digital health.”
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