Huma, a digital health tech company based in the UK, has recently obtained FDA 510(k) Class II clearance for its flexible Software as a Medical Device (SaMD) platform, which is designed to be applicable to various diseases. This clearance also includes Huma's cardiovascular risk score algorithm.
Just three months after receiving EU MDR Class IIb certification, Huma collaborated with Health Canada through the FDA's joint eStar program to acquire FDA clearance. The eStar program aims to streamline the regulatory process for medical device applicants.
Huma's SaMD platform utilizes digital technologies that enable the collection of patient data for self-management or remote access by healthcare providers. The company's technology incorporates companion apps for disease management as well as remote patient monitoring systems.
With the FDA clearance, Huma's platform can now support AI algorithms that employ automated data analytics for diagnosis, screening, clinical decision-making, dosing recommendations, and predictions.
Dan Vahdat, the CEO and founder of Huma, expressed excitement about the FDA clearance, stating, "Now, our partners can quickly launch regulated software for new diseases and use cases on our platform in a matter of weeks, rather than spending years developing and regulating their own solutions. We are thrilled to witness how regulated SaMD, validated algorithms, and GenerativeAI can empower our partners to provide care to more patients with greater efficiency."
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