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Huma receives 510(k) Class II clearance for its disease-agnostic platform

UK-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company’s cardiovascular risk score algorithm. 

The company, which received EU MDR Class IIb certification just three months ago, obtained FDA clearance in partnership with Health Canada through the FDA’s joint eStar program that aims to ease the process of garnered regulation for medical device applicants. 

Huma’s SaMD platform employs digital technologies allowing for patient data to be collected for self-management or accessed remotely by providers. The company’s tech includes companion apps for disease management or remote patient monitoring systems.  

The FDA clearance allows the company’s platform to host AI algorithms using automated data analytics for diagnosis, screening, clinical decision making, recommendations for dosing, and predictions. 

“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 and founder of Huma, said in a statement.


Huma, previously Medopad, was rebranded in 2020. 

The digital health platform has made numerous acquisitions, including purchasing AI and wearable tech companies, Biobeats and Tarilian Laser Technologies. Last year, Huma purchased the London-based patient engagement firm iPLATO

In January, Huma acquired clinical trial data specialist Alcedis, expanding the British company’s digital clinical trial space capabilities. 

Last year, the company announced a partnership with AstraZeneca to launch Software as a Medical Device companion apps pertaining to multiple therapeutic areas aimed at accelerating the adoption of decentralized clinical trials. 

At the time, CNBC reported the pharma giant also took a $33 million stake in the British health tech firm, while Huma acquired AstraZeneca’s disease management platform for asthma and heart failure patients dubbed AMAZE, which the companies would work together to scale.

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