Huma Therapeutics, a leading global digital health company, announced this week that it has received multi-condition US Food and Drug Administration (FDA) 510(k) Class II regulatory clearance for its disease management Software as a Medical Device (SaMD) platform.
Huma’s SaMD platform powers digital health pathways where data is collected from patients for self-management or for assessment remotely by healthcare professionals.
The Class II clearance allows Huma’s platform to serve patients of all ages and with any condition, including pediatrics and pregnancy.
The platform is device-agnostic, which means it can integrate with third-party devices such as heart rate monitors, blood sugar monitors and smart inhalers, enhancing its capabilities and versatility. It can compile the information and provide an analysis, which can alert patients and offer advice to doctors for improving care.
Huma’s technologies include remote patient monitoring systems and companion apps for disease management. Companies working with the platform can launch algorithm innovations in a compliant and quick manner.
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As part of the platform approval, Huma’s AI-powered cardiovascular risk score algorithm also got FDA 510(k) clearance. As part of its ongoing collaboration with Bayer, the tool was launched earlier this year on the Bayer Aspirin website as part of a nationwide screening program aimed at improving cardiovascular health.
Dan Vahdat, CEO and founder of Huma Therapeutics, said, “We are delighted to see our software as a medical device platform cleared for Class II use by the US FDA so that we can provide next-generation health insights and predictions.”
“Now, our partners can launch Class II regulated software for new diseases and use cases in a matter of weeks on our platform, rather than the years they may have taken to develop and regulate their own solution. We are really excited to see how regulated SaMD, validated algorithms and GenerativeAI can enable our partners to care for more patients with less.”
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With Class II clearance, the platform can host AI algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication. This allows healthcare providers to identify at-risk patients, allowing for early intervention and delivering quality care more effectively. It also provides patients greater support for self-management if they display early signs and symptoms that may indicate disease progression.
The platform could also be used in virtual clinical trials to help identify study participants in databases that are continuously updated and then recruit them directly through the platform.
The platform’s compliance with IEC 60601-1-8 allows it to conduct data interpretation triggering on-time alerts, enhancing personalized, clinical decision support and patient notifications.
Huma Therapeutics is one of the first to have a successful comprehensive medical device submission through the FDA’s new, interactive joint eSTAR program with Health Canada. eSTAR aims to increase regulatory efficiency through digitalization.
First approved in Europe under new MDR regulations, the platform is the only disease-agnostic platform to hold both EU MDR Class IIb and US FDA 510(k) Class II regulatory status.
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