CELLS IA TECHNOLOGIES S.L.

CELLS IA Technologies S.L. specializes in automated pathology diagnostic tools that leverage artificial intelligence for image analysis. Their devices focus on detecting and classifying biomarkers for diseases like breast cancer (e.g., HER2, Ki67), colon cancer, melanoma, and bacterial infections. They also provide solutions for digital pathology, including systems for prostate cancer diagnostics, breast cancer assessment, and dermatological imaging. These tools are designed to improve diagnostic precision by analyzing large volumes of tissue samples and nuclear/mitochondrial markers.

CELLS IA Technologies S.L. is based in Spain, which places its devices under the regulatory scope of the European Union’s medical device framework. Since the company’s products are classified as Class A or In Vitro Diagnostic (IVD) General, they must comply with EU Directives and Regulations, including mandatory registration in the eudamed database. This ensures transparency and traceability for authorized devices within the EU market.

The company’s devices are listed in the eudamed registry, which is the official EU database for medical devices and IVDs. This registry is maintained under EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure authorized products are publicly accessible for stakeholders like healthcare providers, regulators, and patients.

CELLS IA Technologies S.L.’s devices fall into two primary classification categories: Class A (low-risk medical devices) and In Vitro Diagnostic (IVD) General (for laboratory-based diagnostics). Classification determines the regulatory requirements, such as risk assessment, technical documentation, and post-market surveillance. For example, IVD devices must meet stringent performance criteria to ensure accuracy in diagnostic results, while Class A devices undergo less stringent scrutiny due to their lower inherent risk.