Mauna Kea Technologies’ Cellvizio obtains FDA 510(k) clearance for use in urology

7 March 2014 (Last Updated November 22nd, 2018 11:26)

French device maker Mauna Kea Technologies has obtained a 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for Cellvizio in the field of urology.

French device maker Mauna Kea Technologies has obtained a 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for Cellvizio in the field of urology.

Cellvizio is claimed to be the only optical biopsy system that can be used for numerous indications and that allows medical staff to assess tissues microscopically with no invasiveness or limit on the number of optical examinations carried out.

This new clearance 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.

This clearance in urology allows the company to expand the potential applications of Cellvizio beyond gastro-intestinal and pulmonary applications.

"This technology offers urologists a new window to visualise urological cancers, particularly bladder, and improve their detection and resection."

Stanford University associate professor of urology Dr Joseph Liao said: "This technology offers urologists an exciting new window to visualise urological cancers, particularly bladder, and improve their detection and resection."

According to the National Cancer Institute, in 2013, an estimated 500,000 people were living with bladder cancer in the US, while 72,570 new cases and 15,210 deaths were associated with the disease.

In 2011, sales of urology devices in the US market were $4.4bn, accounting for 56.9% of the global market share.

Cellvizio has 510(k) clearance from the FDA and the European CE-Mark for use during digestive and pulmonary endoscopy procedures, including pancreatic and biliary endoscopic explorations as well as fine needle aspiration procedures.

In November 2013, Mauna Kea Technologies obtained CE Mark clearance for a complete range of probes dedicated to urology.

Mauna Kea Technologies CEO and founder Sacha Loiseau said: "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."

According to GlobalData estimates, the US flexible endoscopes market was valued at $1.14bn in 2012 and is expected to grow at a CAGR of 4.5% to reach $1.55bn by 2019.