Mauna Kea Technologies secures US FDA 510(k) clearance for confocal miniprobes

25 May 2016 (Last Updated May 25th, 2016 18:30)

French medical device company Mauna Kea Technologies has secured US Food and Drug Administration (FDA) 510(k) clearance for its confocal miniprobes.

French medical device company Mauna Kea Technologies has secured US Food and Drug Administration (FDA) 510(k) clearance for its confocal miniprobes.

With this clearance, confocal miniprobes can now be used with the near-infrared Cellvizio platform for urological and minimally invasive surgical applications.

Cellvizio is an endomicroscopy system, developed by the company, which generates optical biopsies, to provide physicians with microscopic images of tissue in a short timespan involving a minimally-invasive manner.

"Our near-infrared imaging products are designed to provide a positive impact on procedural outcomes by adding to fluorescence-guided procedures the precision and reliability of real-time cellular characterisation."

It facilitates better decision-making and appropriate patient management by means of easy pattern recognition.

Mauna Kea Technologies co-founder and CEO Sacha Loiseau said: "This FDA clearance is another step forward in expanding the utility of the Cellvizio platform in minimally invasive surgery and urological applications.

"Our near-infrared imaging products are designed to provide a positive impact on procedural outcomes by adding to fluorescence-guided procedures the precision and reliability of real-time cellular characterisation.

"In addition to be complementary to existing intra-operative fluorescence systems that use the same near-infrared wavelength, surgical CLE data may bring physicians microscopic guidance in a wide range of surgical procedures."

The surgeons are provided an improved anatomical guidance through an image-guided surgery with intra-operative macroscopic fluorescence systems.

The near-infrared confocal miniprobes integrates with the Cellvizio platform and complements the existing macroscopic near-infrared endoscopic platforms proposed by a majority of surgical endoscopy manufacturers.

The confocal miniprobes can be operated separately by the departments GI endoscopy unit and the bronchoscopy unit which engage the Cellvizio platform, depending on their indications and needs.