Huma receives world's first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform - Seite 2

Jeanne Kehren, Senior Vice President, Digital & Commercial Innovation & Chief Information Officer, Bayer AG, said: "By rigorously working toward this high standard of certification for its technology platform, Huma has demonstrated its dedication to provide an evidence-based, patient-centred and scientifically robust solution and make digital health technology a driver of the healthcare ecosystem transformation."

Dr Mert Aral, Chief Medical Officer at Huma, said: "Demonstrating the clinical efficacy and safety of our technology through this level of regulatory certification is essential for the trust needed to provide accurate, real-time insights to aid clinical decision-making in disease management. Clinicians can now deliver personalised treatment plans based on individual patient needs, medical history and digital biomarkers to optimise health outcomes and tailor the experience to patient preferences."

References:

1. EUDAMED - European Database on Medical Devices

About Huma

Huma Therapeutics is a global digital health technology company that advances digital-first care delivery and research to help people live longer, fuller lives.

Huma's award-winning modular platforms are used by more than 3,000 hospitals and clinics, with 1.8+ million active users in healthcare and 650,000+ participants across research. Huma's regulated Software as a Medical Device is the only platform to hold Class IIb certification status. It powers:

• Digital first care for health systems
• companion apps to support patients through treatment and drug therapies
• virtual clinical trials to accelerate research

Please visit www.huma.com and follow us on LinkedIn at Huma

Media contact:

Karen Birmingham PhD
Head of PR & Communications, Huma
[e-mail]
[phone]

Logo - https://mma.prnewswire.com/media/1427908/Huma_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/huma-receives-worlds-first-and-only-multi-condition-eu-mdr-class-iib-regulatory-approval-for-its-configurable-samd-disease-management-platform-301778889.html