No more beating around the bush here: With a newly bestowed FDA clearance, Huma’s disease-agnostic health management software can now be more direct in offering clinical recommendations to users and their doctors.
Before securing the 510(k) clearance—which Huma announced Monday—the platform could only compile patient data into a single location, from which doctors had to draw their own conclusions. Now, however, it can analyze the data itself, then present its findings as nudges to patients and advice to doctors to improve care.
Huma’s platform collects that information by connecting to companion apps and tools and a range of external wearable devices, including heart rate and blood sugar monitors and smart inhalers, as well as by asking users to self-report their daily symptoms in Huma’s smartphone app. The analysis, meanwhile, is conducted by a host of built-in algorithms.
The software was cleared for use by patients of all ages and conditions. The FDA nod comes shortly after the platform received clearance across the pond under Europe’s new MDR regulations—an achievement that the New York- and London-based company announced at the end of March.
In addition to offering potentially health-improving recommendations, the platform may also level the disease management playing field by providing its FDA-cleared tools to people across the U.S. regardless of their physical or financial ability to access the nation’s highest-quality healthcare facilities.
“There is significant inconsistency in the quality of care patients receive today and fragmentation in implementation of guideline-directed disease management,” Mert Aral, M.D., Huma’s chief medical officer, said in a statement sent to Fierce Medtech. “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.”
The platform could also improve the development of new therapies to help treat that broad user base. Biopharma developers are able to use Huma’s software to power their virtual clinical trials, sifting through continuously updated databases to single out potential study participants then recruiting them directly through the platform.
Along with the clearance for the platform as a whole, Huma also received the FDA’s green light for an artificial intelligence tool integrated into the software. The machine learning AI takes in a variety of demographic and health data then returns an estimate of how likely an individual is to develop cardiovascular disease within the next decade.
The risk score algorithm is the same one powering a heart disease screening tool that launched on the Bayer Aspirin website earlier this year as part of Bayer’s ongoing collaboration with Huma.
Other AI-powered tools could soon follow suit, since Huma’s healthcare provider partners are able to develop their own disease-specific algorithms to be added into the platform. While they’ll each need to be cleared by the FDA as well, choosing to add the algorithms to the already-FDA-cleared Huma platform could significantly speed up the process—from several months or even years down to just “a matter of weeks,” CEO Dan Vahdat said in the announcement.
And after “investing heavily” in the platform to achieve the regulatory clearance, Huma still isn’t done developing its software, Michael Macdonnell, Huma’s global head of healthcare and pharma partnerships, said in a statement sent to Fierce Medtech.
“We’re also investing in algorithms that prognosticate or quantify disease, enabling earlier intervention, including screening; in clinical decision support features, for example prompting the recommended action or checking dosing,” he said.
Additionally, Macdonnell continued, “We’re developing cutting-edge applications of generative AI to empower patients with personalized and highly contextualized health information, plus AI-powered recommendations that allow clinicians to move from managing dozens of patients remotely to hundreds or even thousands.”