Digital health company Huma Therapeutics has received Class II clearance from the US FDA for its disease-agnostic software platform, which is designed to help people live longer, fuller lives.
Boasting remote patient monitoring systems and companion apps for disease management, the company’s platform collects data from patients for self-management or to be assessed remotely by healthcare professionals. The platform is also device-agnostic and can integrate with external third-party devices such as heart rate and blood sugar monitors.
Already used by more than 3,000 hospitals and clinics, achieving Class II clearance means the Huma platform is now permitted to monitor patients of all ages with any condition. Class II level clearance also permits Huma’s platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication.
“There is significant inconsistency in the quality of care patients receive today and fragmentation in implementation of guideline directed disease management,” said Dr Mert Aral, Chief Medical Officer at Huma. “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.”
Class II clearance further enables greater support for patients to drive self-management who display early signs and symptoms that may indicate disease progression and more serious and avoidable events. As part of the platform approval, Huma’s cardiovascular risk score algorithm, currently being rolled out as part of a nationwide screening programme in the US aimed at improving cardiovascular health, was also FDA 510-K cleared.
“This clearance adds to the platform’s recent EU MDR Class IIb approval, making it one of the best regulated such technologies globally,” said Dan Vahdat, CEO of Huma. “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.”
“As a potential partner, this level of clearance gives us confidence that we are working with a highly regulated, safe and evidence-based platform in our care and management of patients,” said Dr Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona.