Sycai Medical Obtains CE Marking for Its Artificial Intelligence Algorithm for Liver Cancer Detection
- In clinical validation, the algorithm achieved a sensitivity of 90,7% and a specificity of 86,8% in detecting liver lesions from routine abdominal CT scans.
- Liver cancer has a high mortality rate because most cases are diagnosed at advanced stages, when treatment options are more limited and survival rates are significantly reduced.
Barcelona, July 13, 2026. Sycai Medical, a company specializing in artificial intelligence applied to medical imaging diagnostics, has obtained CE marking under the European Medical Device Regulation (MDR) for LIRVEA™, its AI-powered solution for the detection and monitoring of solid liver lesions using routine abdominal CT scans.
With this certification, LIRVEA™ becomes a Class IIb medical device authorized for clinical use across Europe. This milestone reinforces Sycai Medical’s commitment to transforming abdominal oncology diagnostics through artificial intelligence tools capable of improving early detection and optimizing radiology workflows.
The new solution automatically identifies solid liver lesions, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), lymphomas, and liver metastases, even when these findings appear incidentally in imaging studies performed for unrelated clinical reasons. In addition, it incorporates longitudinal follow-up capabilities that enable monitoring of lesion progression over time and the generation of structured reports with precise measurements and anatomical localization.
In the company’s clinical validation study, the algorithm achieved a sensitivity of 90,7% and a specificity of 86,8%, demonstrating its ability to assist healthcare professionals in identifying findings that could otherwise go unnoticed in routine clinical practice.
Addressing One of Oncology’s Greatest Challenges
Liver cancer remains one of the leading causes of cancer-related mortality worldwide because many cases are diagnosed at advanced stages, when therapeutic options are more limited. Globally, hepatocellular carcinoma accounts for approximately 80% of all primary liver cancers.
This challenge is particularly significant for radiology departments, which must manage an ever-growing volume of imaging studies, where small lesions can be overlooked, especially when they appear in examinations performed for other clinical indications.
Against this backdrop, artificial intelligence is emerging as a powerful tool to enhance the diagnostic capabilities of healthcare professionals. “One of the biggest challenges in liver cancer is that many lesions are detected too late or are found incidentally in studies requested for other reasons. This represents a missed opportunity for earlier intervention. At Sycai Medical, we work to ensure that no relevant finding goes unnoticed and that radiologists have access to tools that enable faster, more consistent, and more accurate decision-making,” said Alfonso Martínez, CEO of Sycai Medical.
How AI Can Transform Liver Diagnostics
Every day, thousands of abdominal CT scans are performed in European hospitals for reasons unrelated to cancer. Among these images, early-stage liver lesions may be present and, if not detected in time, can progress silently to advanced stages. Increasing clinical workloads, a growing volume of diagnostic imaging studies, and the complexity of certain findings all contribute to the risk of delayed diagnoses and variability among professionals.
LIRVEA™ addresses this challenge through an artificial intelligence system that automatically analyzes CT studies, detects and flags suspicious lesions, characterizes them, performs standardized measurements, and compares previous examinations to assess their evolution. All of this is achieved without altering existing clinical protocols and through seamless integration with hospital PACS/RIS systems.
About Sycai Medical
Sycai Medical is focused on helping radiologists and healthcare professionals in the early diagnosis of cancer in the abdomen. With their unique approach, they create AI algorithms that detect and characterize abdominal lesions, automating further patient monitoring. The company based in Barcelona and incubated at Barcelona Activa, was created by Sara Toledano, Javier García and Júlia Rodríguez in 2020 during the pandemic with the aim of using cutting-edge technologies to empower doctors and improve quality of life of patients.
Sycai Medical media contact: David Varela; david.varela@puentia.com
