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Huma has become the first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform. In this article, Rudolf Wagner, Huma's Global Director of Regulatory Affairs, explains what this achievement means for the future of health care.
Huma Therapeutics, a leading global digital health company, today announced that it 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).
AstraZeneca has been working with Huma to develop a series of software-based tools for monitoring patients. Medtech Insight spoke to both companies about the value of these partnerships and the potential challenges.
Huma is a medtech firm that allows doctors to monitor patients remotely through a mobile app that integrates their data into a dashboard for clinicians to monitor. In 2021 it raised $200 million to scale its digital health platform for better care and research, backed by the likes of Bayer, Hitachi, Samsung, Sony Innovation Fund by IGV, Unilever and the PE fund HAT.
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