Mauna Kea Technologies, a global medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Cellvizio in the field of urology.
The FDA 510(k) approval covers the use of Cellvizio’s Uroflex B and CystoFlex F confocal miniprobes within anatomical tracts including but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
Mauna Kea Technologies claims that the new approval positions the company’s Cellvizio optical biopsy technology for use in a range of urology applications that include bladder imaging during cystoscopy as well as the ureters, where traditional biopsies are very difficult to perform and have poor yield.
Mauna Kea Technologies CEO and founder Sacha Loiseau noted this 510(k) clearance follows the company’s recent AQ-Flex 510(k) clearance for needle-based microscopic imaging applications and further demonstrates our ability to expand our market opportunities for the Cellvizio platform in new indications.
"We are currently evaluating the best options to bring our advanced endomicroscopy technology to the market and thus to patients affected by serious urologic conditions as quickly as possible," Loiseau added.