NEW DATA-DRIVEN CLINICAL SOFTWARE OBTAINS REGULATORY APPROVAL, BRIDGING A CRUCIAL GAP IN THE COMBAT AGAINST A HIDDEN LIVER DISEASE AFFECTING OVER 1 BILLION PEOPLE WORLDWIDE

Evido Health, a Danish digital health startup, has obtained regulatory approval (CE-certificate, IVDR cl-b) for their data-driven clinical tool, LiverPRO. This milestone enables Evido to bridge a crucial gap in the field by enabling timely detection and intervention of Chronic Liver Disease (CLD). A disease that today is undiagnosed in over 200 million Europeans and becomes fatal if detected too late.

Tackling a hidden epidemic 

Steatotic Liver Disease (SLD) is a silent liver disease that progresses without symptoms until it reaches the fatal stage of liver cirrhosis. In fact, 3 out of 4 are diagnosed when it is too late. Driven by rising rates of obesity, diabetes, and alcohol overuse, SLD affects 30% of the world’s adult population, causes 1 million deaths annually, and is the second leading cause of lost working years in Europe. Experts predict an 83% increase in disease prevalence by 2039, likening its future impact to that of diabetes. The lack of effective treatment options and accurate diagnostic tests outside of specialist care has hampered efforts to manage this growing health crisis—until now. 

 

Moving detection and management outside of specialist wards 

Evido Health has recently released their first data-driven solution, LiverPRO, to the European market enabling timely detection of patients while the disease is still reversible. Their innovative solution unlocks valuable clinical insights from already sampled healthcare data, making accurate patient detection possible outside of specialist wards.    

Evido Health is among the first companies globally to obtain CE certification for a software solution under the new European In Vitro Diagnostic Regulation (IVDR).  

 

Leveraging existing healthcare data 

LiverPRO integrates seamlessly with existing patient consultations by utilizing already collected healthcare data. It connects directly with central healthcare infrastructure, delivering results to the physician’s IT system, eliminating manual data entry, and providing specialized clinical recommendations. With the CE certification, Evido Health is taking a huge leap forward and ensuring timely detection of otherwise fatal patients, remove unnecessary referrals, and providing economic benefits for healthcare payers. 

 

Executive insights 

Taus Holtug, CEO and Co-Founder of Evido Health, expressed excitement about recent advancements: “We are proud to be part of the movement ensuring a better future for people struggling with liver disease. Our CE certification comes at a pivotal time, coinciding with the launch of the first direct treatments for MASH. We are looking forward to keep contributing to the field and move the boundaries for data driven support, benefitting both patients, physicians and our overstretched healthcare system. 

 

For further information, please contact: 

Taus Holtug 

CEO and co-founder 

taus@evido.health 

 

About Evido Health 

Evido is a data-driven healthcare technology company focused on improving early detection and monitoring of serious diseases through advanced algorithms and data analytics. Their product, LiverPRO, leverages over a decade of clinical research to enhance the diagnostic accuracy of SLD. With a focus on healthcare systems and pharmaceutical companies, Evido's solution helps enhance patient management and streamline clinical trial processes, resulting in better patient outcomes and significant cost savings.