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Fluoptics gets FDA clearance

Fluoptics, specializing in fluorescence imaging for guided surgery (FIGS), has obtained the Food and Drug Administration clearance for its clinical imaging system, Fluobeam®. The 510(k) authorization specifies that Fluobeam® can be used clinically with the fluorescent molecule indocyanine green (ICG).


“This FDA clearance opens the door for fluorescence imaging for guided surgery with Fluobeam® in the United States. One year after our clinical imaging system got CE-marked, and was introduced in Europe, Fluobeam® is now available in North American operating rooms, with benefits from this technology coming in a large range of surgical applications. It is a key step for the international development and expansion of the company,” rejoiced Odile Allard, chairwoman and CEO of the company.

 

Read the press release