Announcement

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

June 12, 2023
Announcement

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

June 12, 2023

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  • Class II clearance expands the patient population that can be managed 
  • Companies working with Huma's platform can now launch algorithm innovations more quickly in a compliant and de-risked manner, democratising digital health innovation across the industry
  • Clearance was granted through the FDA’s joint eSTAR programme which aims to increase the efficiency of regulation through digitalisation
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NEW YORK & LONDON, June 12, 2023 Huma Therapeutics (“Huma”), a leading global digital health company, today announced that it has received U.S. Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform. This clearance marks a significant milestone in patient monitoring and disease management.

Huma’s SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals (HCPs). Huma’s technologies include remote patient monitoring (RPM) systems and companion apps to enable disease management. 

Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy. The platform is also device-agnostic and can integrate with external third-party devices such as heart rate and blood sugar monitors, as well as smart inhalers, enhancing its capabilities and versatility. 

AI algorithm addition

Class II level clearance permits Huma’s platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication. By harnessing this new functionality, healthcare providers can identify at risk patients, intervene early and deliver high quality care more effectively. Class II clearance further enables greater support for patients to drive self-management who display early signs and symptoms that may indicate disease progression and more serious and avoidable events. As part of the platform approval, Huma’s cardiovascular risk score algorithm, currently being rolled out as part of a nationwide screening programme in the US aimed at improving cardiovascular health, was also FDA 510-K cleared.

Dan Vahdat, CEO & Founder of Huma, said: “We are delighted to see our software as a medical device platform cleared for Class II use by the US FDA so that we can provide next-generation health insights and predictions. This clearance adds to the platform’s recent EU MDR Class IIb approval, making it one of the best regulated such technologies globally. 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.”

Watch Dan explain the importance of FDA Class II clearance to Huma and to the field of digital health.

Dr Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona, said: “I am delighted to see Huma achieve Class II clearance from the US FDA for its technology platform. As a potential partner, this level of clearance gives us confidence that we are working with a highly regulated, safe and evidence-based platform in our care and management of patients.”

Dr Mert Aral, Chief Medical Officer at Huma, said: “Our SaMD platform is used in the diagnosis, treatment, and monitoring of a wide range of diseases, and it is therefore important that it meets the high regulatory standards to demonstrate its safety and effectiveness based on evidence. There is significant inconsistency in the quality of care patients receive today and fragmentation in implementation of guideline directed disease management. The ability of the Huma platform to provide advanced clinical decision support and host algorithms that can diagnose and quantify disease processes will be a game changer for tackling this issue at scale.” 

Huma is one of the first applicants to be successful through the FDA’s new, interactive joint eSTAR programme (with Health Canada) for a comprehensive medical device submission. Huma's compliance with IEC 60601-1-8 now allows the platform to conduct data interpretation triggering on-time alerts, enhancing personalised, clinical decision support and patient notifications.

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 3,000 hospitals and clinics, with 1.8+ million active users in healthcare and 650,000+ participants across research. Huma's regulated Software as a Medical Device is the only disease agnostic platform to hold both EU MDR Class IIb and US FDA Class II regulatory status. It powers:

  • Digital first care for health systems
  • companion apps to support patients through treatment and drug therapies
  • virtual clinical trials to accelerate research

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

Media contact

Karen Birmingham PhD
Head of PR & Communications, Huma
karen.birmingham@huma.com
+44 (0) 7866 609314

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Making an impact

3000+

3000+ hospitals and clinics supported across Huma platforms to secure the most sustainable impact for patients1

×2

Our platform can almost double clinical capacity and reduce readmission rates by >30%3

27m+

Huma's digital-first health platforms support a network of 27m patients1

1m+

Over 1 million devices have been shipped in support of our projects and we know what it takes to deploy at scale1

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Selected as one of 'The Most Important Healthcare Design of 2021' by Fast Company5

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Sources:

Announcement

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

June 12, 2023
Announcement

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

June 12, 2023

Huma joins digital pioneers to advance health equity in care and research

Chief Executive Officer and Founder, Dan Vahdat, is returning to the annual World Economic Forum’s main conference where he will join a panel discussion devoted to improving care for non-communicable disease and tackling health equity. Accompanied by Chief Financial and Strategy Officer, Ingeborg Oie, Dan is looking forward to connecting with other attendees to explore how Huma’s digital health platform can make healthcare more equitable, and advances proactive, predictive care.

Huma joins digital pioneers to advance health equity in care and research

Date:Wednesday, January 18, 2023
Time:4:15 - 5:15 p.m. CET
Location:Ice Village, Eisbahnstrasse 5, Davos, Switzerland
Dan will join the Digital Health Action Alliance panel at Davos to discuss Turning the Tide in Non-Communicable Disease Care Through Digital Health and Community Connection. Huma has a long history of advancing the care of non-communicable diseases (NCDs) such as heart disease, cancer, diabetes and lung conditions. Huma’s innovative remote patient monitoring platform enables broad patient recruitment, reduces reliance on in-person clinic visits and increases health system efficiency.
*This session is open to registered Annual Meeting 2023 participants and Affiliate badge holders.

Huma is one of the first to sign the Zero Health Gaps Pledge

Huma is one of the first signatories to the Zero Health Gaps Pledge, the World Economic Forum’s Global Health Equity Network’s (GHEN) initiative. Huma supports GHEN’s ambition to build a future without disparities in health or wellbeing outcomes. Huma’s digital platform has been built on a deep clinical knowledge of complex patient needs and how people engage with technology and we are committed to ensuring our technology promotes health equity. We are proud to work with governments, hospital groups, universities, life science and technology companies to bring greater scale and impact and help all people live longer, fuller lives.

Huma at World Economic Forum

Global Innovators and Tech Pioneers
Dec 2022: Huma selected to join 100 innovative companies on a two-year journey as part of the World Economic Forum’s initiatives, activities and events, bringing their cutting-edge insight and fresh thinking to critical global discussions.
Learn more
Working Together, Restoring Trust
May 2022: With the aim to address economic, environmental, political, and social fault-lines exacerbated by the COVID-19 pandemic, Dan Vahdat speaks at WEF annual meeting about the importance of scientific collaboration.
Learn more
Accelerating innovation and breaking new ground
October 2022: Dan joined the WEF Biotech Future Forum 2022 to discuss how start-ups are breaking new ground in biotech and changing the way we interact with the world, but also how the sector can earn trust, scale successfully and spot the brightest innovations.
Learn more
Making connections at Davos
Jan 2019: Dan attended WEF as an unofficial attendee and spoke to CNBC about the importance of meeting in-person to make connections.
Learn more

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Announcement

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

June 12, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com
Announcement

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

June 12, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com

NEW YORK & LONDON, June 12, 2023 Huma Therapeutics (“Huma”), a leading global digital health company, today announced that it has received U.S. Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform. This clearance marks a significant milestone in patient monitoring and disease management.

Huma’s SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals (HCPs). Huma’s technologies include remote patient monitoring (RPM) systems and companion apps to enable disease management. 

Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy. The platform is also device-agnostic and can integrate with external third-party devices such as heart rate and blood sugar monitors, as well as smart inhalers, enhancing its capabilities and versatility. 

AI algorithm addition

Class II level clearance permits Huma’s platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication. By harnessing this new functionality, healthcare providers can identify at risk patients, intervene early and deliver high quality care more effectively. Class II clearance further enables greater support for patients to drive self-management who display early signs and symptoms that may indicate disease progression and more serious and avoidable events. As part of the platform approval, Huma’s cardiovascular risk score algorithm, currently being rolled out as part of a nationwide screening programme in the US aimed at improving cardiovascular health, was also FDA 510-K cleared.

Dan Vahdat, CEO & Founder of Huma, said: “We are delighted to see our software as a medical device platform cleared for Class II use by the US FDA so that we can provide next-generation health insights and predictions. This clearance adds to the platform’s recent EU MDR Class IIb approval, making it one of the best regulated such technologies globally. 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.”

Watch Dan explain the importance of FDA Class II clearance to Huma and to the field of digital health.

Dr Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona, said: “I am delighted to see Huma achieve Class II clearance from the US FDA for its technology platform. As a potential partner, this level of clearance gives us confidence that we are working with a highly regulated, safe and evidence-based platform in our care and management of patients.”

Dr Mert Aral, Chief Medical Officer at Huma, said: “Our SaMD platform is used in the diagnosis, treatment, and monitoring of a wide range of diseases, and it is therefore important that it meets the high regulatory standards to demonstrate its safety and effectiveness based on evidence. There is significant inconsistency in the quality of care patients receive today and fragmentation in implementation of guideline directed disease management. The ability of the Huma platform to provide advanced clinical decision support and host algorithms that can diagnose and quantify disease processes will be a game changer for tackling this issue at scale.” 

Huma is one of the first applicants to be successful through the FDA’s new, interactive joint eSTAR programme (with Health Canada) for a comprehensive medical device submission. Huma's compliance with IEC 60601-1-8 now allows the platform to conduct data interpretation triggering on-time alerts, enhancing personalised, clinical decision support and patient notifications.

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About Huma

Huma began its journey in 2011, when the company was founded in London. Since then, Huma has grown to become a global healthcare company, spanning across multiple geographies and operating across four continents.

Learn more