Understanding the regulatory pathway, with Spotlab

Time to read:

1 minute


11 November 2021


Hardian Health


IVD, Regulation, CE marking

SpotLab, a Madrid-based medical diagnostics company, is collaborating with Hardian Health to achieve CE marking for its in vitro diagnostic (IVD) device software. SpotLab uses artificial intelligence (AI) and 3D printing technologies to transform cell phones into medical diagnostic tools in areas such as infectious diseases, hematology and pathology. By combining AI software, an app-based interface and 3D printed hardware, SpotLab has created a comprehensive diagnostic ecosystem. Hardian Health has helped SpotLab navigate complex regulatory frameworks, developing a step-by-step approach to achieving IVD regulation and laying the groundwork for clinical algorithm submission and approval. The successful collaboration between the two companies will enable SpotLab to accelerate the approval of new algorithms for the diagnosis of up to 105 different diseases.