Saudi FDA greenlights Huma’s SaMD disease management platform

Global digital health firm Huma Therapeutics has received Saudi FDA Class C certification for a disease-agnostic Software as a Medical Device (SaMD) in Saudi Arabia.

The Kingdom's ambitious and groundbreaking healthcare program now has a software supplier that can support its vision and growth. Huma'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) programmes, companion apps, risk assessment tools, dose calculators, and algorithms.

Why does it matter?

With the recent attainment of Saudi FDA Class C certification, complementing its existing Class IIb regulatory certification in the EU and Class II 510(k) in the USA, the SaMD platform reaches a new pinnacle in patient care versatility. This achievement enables the platform to monitor patients across all age groups — including infants and those pregnant, and seamlessly integrates with various external devices such as heart rate and blood sugar monitors, and smart inhalers.

Beyond facilitating disease self-management for patients, the platform is equipped to aid clinicians in managing critical and serious conditions — including heart failure, COPD, asthma, cancer, rare diseases, pre-/post-op monitoring and more. Additionally, the platform has the ability to host advanced machine learning algorithms, enhancing its capabilities in risk prediction, diagnosis, and disease progression.‍

The SaMD technology can reduce the burden on HCPs and healthcare systems by:

• Delivering proactive care through advanced triage alerts, filters and flags personalized to individual patients and communicated to clinicians via a customizable dashboards
• Providing personalized insights generated from a patient's medical history and health data, to optimize care and outcomes
• Hosting biomarkers to diagnose, help quantify and monitor conditions that require frequent clinical observations

And it's Huma's solution that can help reduce the time and cost for other companies to bring regulated SaMD products to market — enabling digital health innovation across the industry.

On the record

"We've spent more than a decade developing our technology, and we're thrilled to see it validated not only in Europe and the United States, but now in Saudi Arabia. This milestone represents more than just an approval; it signifies a paradigm shift in digital health innovation. Businesses no longer face the daunting prospect of spending years and potentially at a cost of several millions of dollars developing a regulated app," said Dan Vahdat, CEO & Founder of Huma. "Our Class C-approved platform offers a customizable solution, significantly reducing risk and making digital health innovation more accessible and democratic."

The context

Huma Therapeutics is a global digital health technology company whose modular platforms are used by more than 3,000 hospitals and clinics, with 1.8+ million active users in healthcare and 700,000+ participants across research. Its 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, and virtual clinical trials to accelerate research.

In August, the company announced plans to use Google Cloud's generative AI solution to further support healthcare professionals (HCPs) with better insights to optimize care delivery.