Huma receives FDA approval for SAMD platform

Huma, a digital health company, has received US Food and Drug Administration (FDA) Class II clearance for its disease-agnostic software as a medical device (SaMD) platform.

Huma’s SAMD platform powers digital health pathways through which data is collected for self-management from patients or assessed remotely by healthcare professionals (HCPs). Huma’s technologies include Remote Patient Monitoring (RPM) systems and companion apps to enable disease management.

Achieving a Class II clearance means the platform is allowed to monitor any condition of patients of all ages – including pediatrics and pregnancy. The platform is also device-agnostic and can integrate with external third-party devices such as heart rate and blood glucose monitors as well as smart inhalers, enhancing its capabilities and versatility.

AI Algorithm Addition

The Class II level approval allows Huma’s platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosage recommendations, clinical decision making and forecasting. Using this new functionality, healthcare providers can identify at-risk patients, intervene sooner, and more effectively provide high-quality care. Grade II clearance is more supportive of self-management for patients who exhibit early signs and symptoms that may indicate disease progression and more serious and avoidable events. As part of the platform’s approval, HUMA’s cardiovascular risk score algorithm, currently being rolled out in the US as part of a nationwide screening program aimed at improving cardiovascular health, is approved by FDA 510-K Approval was also received.

Dan Wahdat, CEO and Founder of Huma, said: “We are pleased to see our software granted Category II use by the US FDA as a medical device platform so that we can provide next-generation health insights and predictions. This clearance platform K.’s recent EU MDR Class IIB approval, making it one of the few such technologies globally. Now, our partners can be Class II regulated for new diseases instead of the years it would take to develop and regulate their own solutions. can launch software and use cases on our platform in as little as a matter of weeks. We’re really excited to see how regulated SaMD, validated algorithms and GenerativeAI can enable our partners to care for fewer patients Are.

Dr. Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona, said: “I am pleased with Huma receiving Category II approval from the US FDA for its technology platform. As a potential partner, this level of Clearance assures us that we are working with a highly regulated, safe and evidence-based platform in the care and management of patients.