Medizinprodukt
The majority of clinical trials have focused on applications in the gastro-intestinal (GI) tract, particularly the detection and characterisation of pre-cancerous lesions. OptiScan's FIVE2 has been certified to ISO 13485:2016 in alignment with 21CFR820 and EU Medical device regulations for installation of the scanner into medical devices while Mauna Kea’s Cellvizio has US Food and Drug Administration (FDA) 510(k) clearance and a European CE Mark for clinical use in the GI and pulmonary tracts. Research studies have suggested a large range of potential applications, including in the urinary tract, head and neck, ovaries, and lungs. Commonly used fluorescent stains include topically applied acriflavine, and intravenously administered fluorescein sodium.