Our Chronic Kidney Disease Screening Prioritizer (CSP) has received a UKCA marking and regulatory approval meaning it is a registered medical device in the UK.
UKCA marking is a certification mark that indicates that a product meets the safety, health, and environmental protection standards set by the UK government. In addition, regulatory approval confirms that Gendius has met all the requirements and standards set by the regulatory bodies that oversee the industry. This approval is not only a sign of credibility it allows the expansion of our CSP product into the UK market.
Our CSP product is a digital pre-screening solution that risk stratifies patients to enable precision screening. In early CKD diagnosis and intervention are key, with the often silent and undiagnosed disease, screening is vital to help identify patients. Our solution makes screening smarter by understanding the patient and the system needs. With no laboratory test required our solution is globally scalable and supports clinical decision-making. Read more about our product here.
This is a significant accomplishment that demonstrates Gendius’ commitment to compliance and quality assurance. This approval would not have been possible without our in-house expert in Medical Device Quality and Regulatory compliance Ali Borazjani and the incredible hard work of the wider team.
Ali has a proven track record of successful projects for market-leading medical device companies. With his expertise and experience, Ali is a valuable asset to us here at Gendius as we look to ensure compliance and bring safe and effective products to market.
After this success, Ali and the rest of our team are now focused on achieving CE approval, followed by FDA approval, as the next steps on our regulatory roadmap.
Extending regulatory approval outside of the UK market means that patients worldwide can benefit from our globally scalable CSP solution.
This achievement marks a major milestone in Gendius’s journey towards improving patient lives and reducing the burdens faced by healthcare systems worldwide.
We hope to updating you with more good news again shortly.