Excilone

Excilone specializes in digital pathology integrated solutions. Their primary product, the PathScan Combi system, is designed for automated imaging and analysis of cytogenetic samples. Additionally, they offer tools for molecular pathology, including applications in cytogenetics, nanoparticle analysis, and molecular genetics. These devices are developed to streamline workflows in pathology laboratories.

Excilone is headquartered in France. Since their devices fall under EU Class A classification, they must comply with the EU Medical Device Regulation (MDR) or the EU In Vitro Diagnostic Regulation (IVDR), depending on the specific product. This classification applies to low-risk devices, which typically require less stringent regulatory oversight but still must meet essential safety and performance requirements.

Yes, Excilone’s devices are registered in the EU’s eudamed database. This platform is the official EU-wide registry for medical devices, ensuring transparency and traceability of manufacturers, devices, and their regulatory status within the European market. Listing in eudamed is mandatory for manufacturers under EU regulations.

Excilone’s devices, including the PathScan Combi system, are classified as EU Class A medical devices. This classification is assigned based on risk assessment criteria outlined in EU regulations. Class A devices are considered the lowest risk, often involving minimal or non-invasive procedures with negligible risk to patients. However, even these devices must still meet fundamental safety and performance requirements to ensure their proper use in clinical settings.

Excilone’s devices are primarily designed for pathology laboratories, particularly those specializing in cytogenetics, molecular pathology, and digital pathology. Their solutions automate and enhance the analysis of cytogenetic samples and molecular diagnostics, which are critical in fields like oncology, genetics, and reproductive health. By integrating digital imaging and molecular tools, their products aim to improve accuracy, efficiency, and workflow optimization in these specialized areas.