The U.S. Food and Drug Administration (FDA) has granted fluorescence imaging company Fluoptics authorization to market Fluobeam 800 for detecting parathyroid tissue during surgery.
The handheld fluorescent imaging device received 510(k) clearance in 2014 for examining blood flow at surgical sites using fluorescence imaging. It relies on a fluorescent dye -- indocyanine green -- to spot parathyroid tissue, removing the need for a contrast agent.
Fluoptics has now received FDA approval to promote the use of Fluobeam 800 as a supplementary imaging device for locating parathyroid tissue in real-time, which is critical for procedures such as thyroidectomy and parathyroidectomy.
Fluobeam 800 is not intended to replace standard visual assessment and biopsy when confirming the presence of parathyroid tissue; rather, it is intended to help clinicians locate tissue during surgery, the FDA noted.
The agency reviewed Fluobeam 800 through its de novo premarket review pathway for new types of low- to moderate-risk devices, taking into account data from five peer-reviewed studies.
