Source – HUMA
With the FDA’s Class II clearance of its Software as a Medical Device (SaMD) disease management platform, Huma Therapeutics’ scope of services is now significantly broader.
Having received Class II clearance, the platform may now be used to offer clinical recommendations for treatment, whereas it was previously only permitted to gather patient data and transmit it to physicians, who would then evaluate the findings and determine a care plan.
According to Huma, no other digital health firm in the US or EU has received this level of certification for its disease-agnostic SaMD. Importantly, it indicates that more businesses may now add algorithms to the platform and get them approved for usage in a matter of weeks as opposed to possibly years if they were to individually seek clearance.
“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. 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. We are really excited to see how regulated SaMD, validated algorithms and GenerativeAI can enable our partners to care for more patients with less.”
– Dan Vahdat, CEO & Founder of Huma
“I am delighted to see Huma achieve Class II clearance from the US FDA for its technology platform. 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.”
– Dr Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona
“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 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.”
– Dr Mert Aral, Chief Medical Officer at Huma
The FDA’s joint eSTAR initiative, which seeks to improve the effectiveness of regulation through digitization, was responsible for the approval. According to Huma, it is among the first candidates to be accepted into the scheme for a thorough medical device submission.
The recent approval obtained by Huma will greatly facilitate its expansion into the US market. In addition to the platform approval, Huma has also received regulatory clearance for a cardiovascular risk score algorithm, which was developed in collaboration with Bayer. This algorithm is currently being implemented as a crucial component of a nationwide cardiovascular screening program in the United States. This accomplishment signifies a significant milestone for Huma, as it not only enables the company to introduce its platform to a broader audience but also showcases its expertise in developing innovative solutions for managing cardiovascular health. The partnership with Bayer further strengthens Huma’s credibility and positions it as a key player in the healthcare technology sector, particularly in the field of cardiovascular care.
