Welcome to next-generation digital-first care and research

Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified condition.

Huma’s globally scalable platform offers clinicians new and enhanced digital capabilities to help provide better care to a wider range of more complex patients. Our platform can provide automated advice and guidance directly so patients can better manage their medical conditions from anywhere.

Regulatory, safety and compliance

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EU MDR 2017/745 Class IIb certified

MHRA registered Medical Device Class IIb

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21CFR820 US FDA Class II

US Food and Drug Administration Medical Device 510k # K230214

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ISO certifications

ISO 13485: 2016 certified (Medical Devices: Quality Management Systems)

ISO 27001: 2013 certified

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Data protection / infosec

Committed to GDPR compliance

NHS Registration on Data Security and Protection Toolkit

CyberEssentials / CyberEssentials Plus


Discover what Huma’s regulated platform means for the future of healthcare

Digital technology is transforming healthcare. Huma is at the forefront of this revolution as our Software as a Medical Device (SaMD) digital health platform , now has FDA 510 (k) Class II clearance for any physician specific condition.

Download our complimentary 12-page guide and discover how Huma's platform addresses some of the most pressing healthcare challenges faced by both patients and clinicians.

Content includes:

  • Smarter patient care and optimization
  • Improving clinical outcomes
  • Improved patient engagement and adherence
  • Collecting real world evidence at scale

Download now to discover more.

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Support a wider range of more complex patients with personalised care plans

FDA 510(k) Class II clearance expands the patient population to now include peadiatrics and during pregnancy.

Clinicians can now set specific thresholds and develop personalised treatment plans based on individual patient needs and user preferences to optimise health outcomes.

Enhanced decision support tools can now provide clinicians analytical insights for patients including paediatrics and patients with comorbidities.


More predictive, more proactive patient care

Huma’s FDA 510(k) Class II remote monitoring platform provides clinicians with near real-time continuous data capture and reporting, delivering smarter, more personalised insights generated from a patient's medical history, symptoms, and digital biomarkers.

We can now use predictive algorithms, risk stratification models, or data analysis to identify patients at higher risk and enable proactive intervention.


Better insights, smarter care

We can aid in treatment planning by analysing patient-specific data and providing recommendations using  algorithms to help clinicians personalise treatment plans. We can also monitor patients' progress during treatment and provide feedback to healthcare professionals.

It allows us to offer the following  dosing suggestions, treatment algorithms, or other relevant information to help healthcare professionals optimise patient care.


High-trust, interoperable and compliant

Huma is redefining the digital health landscape with a single, interoperable platform certified for use across multiple therapeutic areas and patient cohorts, featuring digital biomarkers and third-party AI and device integrations, as well as third-party FDA- and MHRA-approved SDK integrations.

Our globally scalable platform is a CE marked medical device EU MDR Class IIb, registered in the EU, UK, US, and Saudi Arabia. We are certified under ISO 13485, ISO 27001 and Cyber Essentials Plus, and are FDA Class II cleared and GxP compliant.

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