SAUDI ARABIA – Global digital health firm Huma Therapeutics has been granted multi-condition Saudi FDA Class C regulatory certification for its Software-as-a-Medical-Device (SaMD) disease management platform.

With the Saudi FDA Class C certification, Huma’s SaMD technology can be used to significantly reduce the burden on healthcare professionals and the nation’s healthcare system.

Class C certification expands the patient population and level of disease severity that can be managed thus allowing the delivery of personalized care through the use of predictive algorithms.

In a press release, Dan Vahdat, Chief Executive Officer and Founder of Huma, said: “We’ve spent more than a decade developing our technology and we are thrilled to see it validated not only in Europe and the United States, but now in the Kingdom of Saudi Arabia.”

The recent attainment of Saudi FDA Class C certification complements Huma’s existing Class IIb regulatory certification in the European Union and Class II 510(k) in the United States of America.

Headquartered in the United Kingdom, Huma is a remote patient monitoring platform for pharma companies and medical providers.

The digital health startup aims to advance digital-first care delivery and research to help people live longer, fuller lives.

In just two years, Huma has acquired two other companies, including digital clinical trials startup Alcedis and patient engagement platform iPLATO.

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 700,000+ participants across research.

Strikingly, Huma’s regulated SaMD is currently the only disease-agnostic platform to hold both EU MDR Class IIb and US FDA Class II regulatory status.

It should be pointed out that this platform is ready to use, reducing the time and cost for other companies to bring regulated SaMD products to market, democratizing digital health innovation across the industry.

On this matter, Huma CEO Dan Vahdat highlighted: “Businesses no longer face the daunting prospect of spending years and potentially at a cost of several millions of dollars developing a regulated app.”

Beyond facilitating disease self-management for patients, the platform is equipped to aid clinicians in managing critical and serious conditions, including heart failure, asthma, cancer, and rare diseases.

The SaMD platform powers digital health pathways through which sets of data are collected from patients for self-management or to be assessed centrally by clinicians.

These records encompass remote patient monitoring (RPM) programmes, companion apps, risk assessment tools, dose calculators, and algorithms.

Additionally, the platform can host advanced machine learning algorithms, enhancing its capabilities in risk prediction, diagnosis, and disease progression.‍

The SaMD technology delivers proactive care through advanced triage alerts, filters and flags personalised to individual patients and communicated to clinicians via a customisable dashboard.

The platform also provides personalized insights generated from a patient’s medical history and health data, specifically intended to optimize care and outcomes.

On top of this, Huma’s regulated SaMD hosts biomarkers to diagnose, help quantify, and monitor conditions that require frequent clinical observations.

Our Class C-approved platform offers a customizable solution, significantly reducing risk and making digital health innovation more accessible and democratic,” highlighted Dan Vahdat.

The Saudi FDA Class C certification means that Huma’s disease management platform can now be used to provide clinical advice and recommendations for treatment in the Kingdom of Saudi Arabia.

For this reason, the Kingdom of Saudi Arabia’s ambitious and groundbreaking healthcare program now has a software supplier that can support its vision and growth.

Another advantage of the Saudi FDA Class C certification is that the SaMD platform is anticipated to reach a new pinnacle in patient care versatility.

This certification enables the SaMD platform to monitor patients across all age groups and seamlessly integrates with various external devices.

for his part, Dan Vahdat reflected: “This milestone represents more than just an approval; it signifies a paradigm shift in digital health innovation.”

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