LUXEMBOURG, Nov. 21, 2023 /PRNewswire/ -- Huma Therapeutics ("Huma"), a pioneering digital health company headquartered in the United Kingdom, announced today that it has achieved Saudi FDA Class C status for a disease-agnostic Software as a Medical Device (SaMD) in the Kingdom.
It is now possible for the Kingdom's ambitious and groundbreaking healthcare program to grow and prosper thanks to the support of a software provider. Through the SaMD platform, Huma powers digital health pathways that collect data from patients to enable patients to manage their own health or to be assessed by clinicians centrally. In addition to remote patient monitoring (RPM) programmes, companion apps, risk assessment tools, dose calculators, algorithms, and so on, there are also companion apps.
In the recent past, the SaMD platform has reached another pinnacle in patient care versatility with the acquisition of the Saudi FDA Class C certification, complementing its existing Class IIb regulatory certification in the EU and Class II 510(k) regulatory certification in the US.. The platform will now be able to monitor patients of all ages, including infants and pregnant women, as well as integrate seamlessly with a variety of external devices, such as heart rate monitors and blood sugar monitors, as well as smart inhalers as well.. As well as facilitating disease self-management for patients, the platform is also equipped to aid clinicians in managing critical and serious conditions, such as heart failure, COPD, asthma, cancer, rare diseases, pre- and post-operative monitoring, and other health conditions.. The platform is also capable of hosting advanced machine learning algorithms, which further enhances its capabilities in risk prediction, diagnosis, and disease progression by being able to facilitate advanced machine learning algorithms
The platform is also capable of hosting advanced machine learning algorithms, which further enhances its capabilities in risk prediction, diagnosis, and disease progression by being able to facilitate advanced machine learning algorithms
Using SaMD technology can reduce the burden on healthcare providers and healthcare systems in the following ways:
As Dan Vahdat, CEO & Founder of Huma, commented: "We have invested more than a decade in developing our technology, and we're thrilled that it has now been validated not only in Europe and the United States, but now in Saudi Arabia as well.". As a result of this milestone, more than just an approval has been achieved; it symbolizes a paradigm shift in the field of digital health. It is no longer necessary for businesses to spend years and potentially several million dollars developing regulated apps due to the fact that they are no longer required to do so. With our Class C-approved platform, we offer a customized solution that reduces risk and makes digital health innovation more accessible and democratic while significantly reducing costs.
With our Class C-approved platform, we offer a customized solution that reduces risk and makes digital health innovation more accessible and democratic while significantly reducing costs.
??The Huma Therapeutics Company is a global digital health technology company that specializes in digital-first care delivery and research, to help people live longer, healthier lives.
There are over 3,000 hospitals and clinics across the country that use Huma's award-winning modular platforms, which have over 1.8 million active users in healthcare and over 700,000 participants in research. Our Software as a Medical Device platform is the only one to hold Class IIb certification. It powers:
We invite you to visit www.huma.com and follow us on LinkedIn at Huma.
Here is the logo - https://mma.prnewswire.com/media/1427908/Huma_Logo.jpg    
Huma is the source of this information
As part of a collaboration between Huma Therapeutics ("Huma"), a leading global digital health company, and Merck KGaA, Darmstadt, Germany, one of the world's leading science and technology companies, a collaborative...
Get PRN's top stories and curated news delivered to your inbox each week when you subscribe!

Source prnewswire