Huma secures Saudi FDA Class C for multi-condition SaMD platform

Huma Therapeutics, a leading global digital health company, has achieved Saudi FDA Class C certification for its Software as a Medical Device (SaMD) platform in Saudi Arabia. This certification, in addition to its existing regulatory certifications in the EU and the USA, marks a significant milestone for Huma's SaMD platform. 

The Class C certification expands the platform's capabilities, allowing it to monitor patients across all age groups, including infants and pregnant individuals. The platform seamlessly integrates with various external devices, such as heart rate and blood sugar monitors, and smart inhalers.

Huma's SaMD platform facilitates various digital health pathways, including remote patient monitoring (RPM) programs, companion apps, risk assessment tools, dose calculators, and advanced machine learning algorithms. The platform's versatility enables personalised care delivery through predictive algorithms, providing proactive care and personalised insights from a patient's medical history and health data.

The SaMD technology aims to reduce the burden on healthcare providers (HCPs) and healthcare systems by delivering advanced triage alerts, personalised insights, and hosting biomarkers for diagnosing and monitoring conditions requiring frequent clinical observations. 

With over a decade of development, Huma's Class C-approved platform is positioned to democratise digital health innovation, significantly reducing the time and cost for companies to bring regulated SaMD products to market. 

Dan Vahdat, CEO & Founder of Huma, emphasised the milestone as a transformative moment in the digital health sector, providing businesses with a customisable solution that reduces risk and enhances accessibility to digital health innovation.