The FDA 510(k) Class 2 approval will help companies working with Huma’s platform can now launch algorithm innovations rapidly in a compliant and de-risked manner, democratising digital health innovation across the industry
Huma’s SaMD platform approved in US. (Credit: National Cancer Institute on Unsplash)
Huma Therapeutics has received the US Food and Drug Administration (FDA) Class 2 approval for its disease-agnostic Software as a Medical Device (SaMD) platform.
The FDA Class 2 approval allows the company’s SaMD platform to monitor patients of all ages with any condition, including paediatrics and in pregnancy.
It allows the platform to host artificial intelligence (AI) algorithms to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication.
Also, it further enables patients to drive self-management who display early signs and symptoms that may indicate disease progression and more serious and avoidable events.
Huma founder and CEO Dan Vahdat said: “We are delighted to see our software as a medical device platform cleared for Class 2 use by the US FDA so that we can provide next-generation health insights and predictions.
“This clearance adds to the platform’s recent EU MDR Class IIb approval, making it one of the best-regulated such technologies globally.
“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.”
Huma’s SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals.
The platform is also device-agnostic, which can integrate with external third-party devices such as heart rate and blood sugar monitors, along with smart inhalers.
Huma offers technologies including remote patient monitoring systems (RPM) and companion apps to support disease management.
Its SaMD platform will harness the new functionality to help healthcare providers identify at-risk patients, intervene early, and deliver high-quality care.
The FDA approval of the platform also includes FDA 510-K approval of Huma’s cardiovascular risk score algorithm, currently offered as part of a nationwide screening programme in the US.
Huma chief medical officer Mert Aral said: “Our SaMD platform is used in the diagnosis, treatment, and monitoring of a wide range of diseases, and it is therefore important that it meets the high regulatory standards to demonstrate its safety and effectiveness based on evidence.
“There is significant inconsistency in the quality-of-care patients receive today and fragmentation in the implementation of guideline-directed disease management.
“The ability of the Huma platform to provide advanced clinical decision support and host algorithms that can diagnose and quantify disease processes will be a game changer for tackling this issue at scale.”