COMUNICADO: Huma receives world's first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD dise

NEW YORK and LONDON, March 22, 2023 /PRNewswire/ -- Huma Therapeutics ("Huma"), 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)1.

COMUNICADO: Huma receives world's first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD dise

NEW YORK and LONDON, March 22, 2023 /PRNewswire/ -- Huma Therapeutics ("Huma"), 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)1. This level of regulatory certification makes Huma's technology the highest classified configurable disease agnostic platform in the sector today.

The company's SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed centrally by clinicians. These include remote patient monitoring (RPM) systems, companion apps, risk assessment tools, dose calculators, algorithms.

Achieving Class IIb certification means that the SaMD platform is permitted to monitor patients of all ages with any condition - including infants and in pregnancy - and can connect with a range of external devices, such as heart rate, blood sugar monitors or smart inhalers. In addition to enabling disease self-management by patients, it can also support clinicians to manage serious and critical conditions such as heart failure, COPD exacerbations, surgical recovery, cancer, immunodeficiency, asthma attacks and more. The platform is now able to host machine learning algorithms that can support risk prediction, diagnosis and prognostication.

The platform can reduce burden on HCPs and healthcare systems by:

Dan Vahdat, CEO

Jeanne Kehren, Senior Vice President, Digital

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:

About them

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:

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

Media contact:

Karen Birmingham PhDHead of PR

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

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

NEXT NEWS