Announcement

Huma Secures Clearance for Class C Medical Device Certification in India

First published:
August 27, 2024
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August 2024 – Huma Therapeutics ("Huma"), a leading global healthcare AI company, announced today that it has received Class C certification from the Central Drugs Standard Control Organisation (CDSCO) for its disease-agnostic, configurable Software as a Medical Device (SaMD) in India. 

This significant regulatory milestone underscores Huma's commitment to expanding its innovative healthcare solutions across emerging markets, particularly in India, where the demand for scalable, digital-first healthcare is rapidly growing. 

The CDSCO certification follows a series of regulatory achievements that made Huma the first and only configurable, disease-agnostic digital health platform with FDA Class II, EU MDR Class IIb, Australia TGA Class IIb and Saudi FDA Class C clearance. 

Across all of these markets, Huma’s flagship product is cleared to monitor patients across all age groups and it is equipped to aid clinicians in managing critical and serious conditions. Additionally, the platform has the ability to host advanced machine learning algorithms, enabling enhanced risk assessment, diagnosis, and predictive monitoring of disease progression.‍

Dan Vahdat, CEO and Founder of Huma, said: “Our mission has always been to bring the best care to everyone, from the richest families to the poorest. Digital solutions can make healthcare accessible, consistent, and proactive, and I’m thrilled that with this approval, we can begin impacting 1.5 billion people in India."

Last month, Huma officially launched the Huma Cloud Platform. The Huma Cloud Platform features a comprehensive library of pre-built modules, plug-ins, content management system and device connectivity options, all of which have been cleared by global regulatory bodies. This enables users to create digital health solutions for any therapeutic area, using simple drag-and-drop functionality, significantly cutting down on development time and costs.  

To read more about the Huma Cloud Platform, please visit workspace.huma.com and join the waitlist to access the Beta version.

With the CDSCO certification, Huma aims also to support the health tech ecosystem in India by empowering startup founders with a flexible, user-friendly tool to enable them to rapidly develop and launch digital health solutions.


About Huma

Huma is a global healthcare AI company on a mission to accelerate the adoption of digital solutions in care and research. Its award-winning modular platforms are used by more than 3,000 hospitals and clinics, with over 35 million screened users and 4 million registered users in healthcare, and has powered over 800 studies supporting about 1 million participants across research. The company is renowned for its role in major national healthcare projects worldwide, from the US and the UK to Germany, Greece, and Saudi Arabia, as well as collaborating with most large pharma companies.

Huma's technology powers:

  • multi-channel patient engagement at population-wide scale for healthcare systems
  • remote patient monitoring (RPM) at scale
  • companion apps to support patients through treatment and drug therapies
  • digital clinical trials, including decentralised trials, to accelerate medical research

Huma's regulated Software as a Medical Device, used in its RPM and companion app solutions, is the only disease- and device- agnostic platform to hold EU MDR Class IIb, US FDA (510-k) Class II clearance and Class IIb registration with the UK MHRA. The SaMD platform is regulated to accept artificial intelligence algorithms and monitor patients of all ages.

Please visit www.huma.com and follow us on LinkedIn at Huma