Milestone enables broader patient population coverage and accelerated digital health innovation across Canada.
April 17, 2025- New York - Huma Therapeutics ("Huma"), a leading global digital health company, today announced that it has received Health Canada Class II Medical Device License for its disease-agnostic Software as a Medical Device (SaMD) platform. This approval represents a significant advancement for digital health and remote patient monitoring in Canada.
Huma Cloud Platform powers comprehensive digital health pathways that enable data collection from patients for self-management or remote assessment by healthcare professionals. The platform's technologies include sophisticated remote patient monitoring (RPM) systems and companion applications designed for effective disease management.
The Class II Medical Device License allows Huma Cloud Platform to monitor patients of all ages with any condition – including pediatric patients and those who are pregnant. The platform's device-agnostic architecture enables seamless integration with external third-party devices such as heart rate monitors, blood glucose meters, and smart inhalers, significantly enhancing its versatility and clinical utility.
Enhanced AI Capabilities for Canadian Healthcare
The Class II license permits Huma Cloud Platform to incorporate artificial intelligence algorithms utilizing automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making, and prognostication. This advanced functionality will enable Canadian healthcare providers to identify at-risk patients earlier, intervene proactively, and deliver higher quality care more efficiently. The license further enhances support for patient self-management by identifying early signs and symptoms that may indicate disease progression, potentially preventing more serious and avoidable events.
Dan Vahdat, CEO & Founder of Huma, said: "We’re proud to announce that our Huma Cloud Platform has received Class II Medical Device License approval from Health Canada—an important milestone that enables us to deliver cutting-edge health insights and predictive tools to patients across the country. This recognition, alongside our FDA Class II clearance and EU MDR Class IIb certification, positions our platform among the most thoroughly regulated digital health technologies worldwide. For our Canadian partners, this opens the door to rapidly deploying regulated software solutions—powered by validated algorithms and advanced AI—for a wide range of conditions. What once took years to build and approve can now be achieved in a matter of weeks. This is a major step forward in expanding access to high-quality, data-driven care for patients throughout Canada."
Dr. Mert Aral, Chief Medical Officer at Huma, said: "Achieving Class II medical device approval in Canada underscores the safety, reliability, and clinical value of our platform. Designed to support diagnosis, treatment, and ongoing monitoring across a wide range of conditions, this approval reflects our commitment to the highest regulatory standards. In the face of fragmented care and inconsistent application of evidence-based guidelines—challenges that also impact Canada’s healthcare system—Huma Cloud Platform offers scalable, advanced clinical decision support and the capability to integrate diagnostic algorithms, paving the way for more consistent and effective care delivery nationwide."
Huma's successful application through Health Canada's Medical Devices Directorate follows multiple other regulatory clearances including the USFDA, demonstrating the company's commitment to meeting the highest regulatory standards across North America. The platform's compliance with IEC 60601-1-8 enables sophisticated data interpretation with timely alerts, enhancing personalized clinical decision support and patient notifications for Canadian users.
About Huma
Huma Therapeutics is a global digital health technology company that advances digital-first care delivery and research to help people live longer, fuller lives. Huma's award-winning modular platforms are used by more than 4,500 hospitals and clinics, with more than 3 million active users. Huma's offering works across different disease areas and powers:
- 'Hospitals at Home'
- Software as a Medical Device (SaMD) solutions
- DCT platforms to support digital clinical trials
Huma's Cloud Platform has been shown to almost double clinical capacity, reduce readmissions by over a third, enable better diversity, participant retention and protocol adherence, while allowing trials to run within weeks. Please visit www.huma.com and follow us on LinkedIn at Huma.
