Patient Engagement/Monitoring

Huma receives EU MDR Class IIb regulatory approval for SaMD

  • Huma’s platform is ready to use, reducing the time and cost for other companies to bring regulated SaMD products to market, democratising digital health innovation across the industry
  • Class IIb certification expands the patient population and level of disease severity that can be managed; allowing delivery of personalised care through the use of predictive algorithms
  • Clinical evidence from over 20 peer-reviewed publications and studies were submitted for regulatory assessment of clinical safety and efficacy

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:

  • offering enhanced decision-making tools for clinicians, such as treatment and diagnostic recommendations for serious conditions
  • delivering proactive care through advanced triage alerts, filters and flags personalised to individual patients and communicated to clinicians via a customisable dashboard
  • providing advanced personalised insights generated from a patient’s medical history and health data, to optimise care and outcomes
  • hosting biomarkers to diagnose and monitor conditions that require frequent clinical observations

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.”

Jeanne Kehren, Senior Vice President, Digital & Commercial Innovation and Chief Information Officer Pharmaceuticals, Bayer AG, said: “By rigorously working towards this high standard of certification for its technology platform, Huma has demonstrated its commitment to providing an evidence-based, patient-centred and scientifically robust solution, and to making digital health technology a driver of the healthcare ecosystem transformation”. Bayer is a long-time investor in Huma through its venture capital arm, Leaps by Bayer.

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.”

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