Huma's Configurable SaMD Disease Management Platform Granted FDA 510(k) Class II Clearance for Multiple Conditions

Monday, June 12, 2023

Huma Therapeutics, a global digital health company, has announced the FDA Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform. This clearance allows Huma to monitor patients of all ages with any medical condition, including pediatrics and pregnancy. The platform is device-agnostic and can integrate with various third-party devices like heart rate monitors and smart inhalers.

The FDA Class II clearance also permits Huma's platform to host artificial intelligence algorithms for automated data analytics. This functionality enables screening, diagnosis, dosing recommendations, clinical decision-making, and prognostication. Healthcare providers can identify at-risk patients and intervene early, improving the quality of care. It also supports patient self-management by identifying early signs and symptoms of disease progression.

The clearance also includes Huma's cardiovascular risk score algorithm, which is part of a nationwide screening program in the US aimed at improving cardiovascular health.

Dan Vahdat, CEO & Founder of Huma, expressed excitement about the FDA clearance, noting that it allows partners to quickly launch regulated software for new diseases and use cases on the platform. The SaMD platform's regulated nature, validated algorithms, and GenerativeAI capabilities enable partners to provide care to more patients efficiently.

Medical professionals have welcomed the Class II clearance, acknowledging its importance in ensuring the safety, effectiveness, and evidence-based nature of the platform. They believe that Huma's SaMD platform, with its advanced clinical decision support and hosting capabilities for disease diagnosis and quantification algorithms, will address current inconsistencies and fragmentation in disease management practices.

Huma's compliance with IEC 60601-1-8 standards allows the platform to conduct data interpretation and deliver timely alerts, enhancing personalized clinical decision support and patient notifications.

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