Mauna Kea (ENT:MKEA) said today it won CE Mark approval in the European Union for its Cellvizio 800 near-infrared platform for endomicroscopic navigation during minimally invasive surgery.
The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said. The device is now indicated for use in gastroenterology, pulmonary and urinary treatments, the Paris-based company said.
“This new regulatory step underlines our growing efforts and presence in the surgical arena through an expanded and dedicated product line. With this novel endomicroscopy platform now operating in the same setting and the same wavelength as widely used macroscopic imaging surgical platforms, we are well positioned to take fluorescence-guided surgery to the next level of precision and reliability,” CEO Sacha Loiseau said in prepared remarks.
The Cellvizio platform is complementary to existing platforms, such as the Intuitive Surgical‘s (NSDQ:ISRG) Firefly, the company said.
In May, Mauna Kea won expanded CE Mark approval in the European Union for Cellvizio imaging device specifically for use in minimally invasive laparoscopic surgical indications.
Cellvizio already won 510(k) clearance from the FDA and a CE Mark for Cellvizion’s use in the GI tract, biliary and pancreatic ducts and lungs, the French device manufacturer said. Cellvizio also has SFDA approval in China and MHLW approval in Japan, Paris-based Mauna Kea said.