The China State Food & Drug Administration approved Mauna Kea Technologies’ Cellvizio confocal endomicroscopy system, a device design to see cancer faster.
Mauna Kea Technologies launched a strategic partnership with Fujifilm Holdings (TSE:4901) subsidiary Fujifilm China Investment Co., Ltd., to develop its optical biopsy market throughout China in various indications, according to the press release.
"We are pleased to add Cellvizio to our broad portfolio of endoscopic products that we offer physicians throughout China," Fujifilm China president Koji Yokota said in prepared remarks. "Optical biopsies allow physicians to diagnose and treat their patients in real time and are a true differentiating factor in endoscopy. Cellvizio will complement and enhance our own proprietary suite of advanced endoscopic imaging devices and systems."
Cellvizio is a probe-based confocal laser endomicroscopy system, which provides high-resolution cellular views of tissue inside the body.
There are 800 advanced endoscopy centers in tertiary referral hospitals in China, which will constitute the primary target for Cellvizio, according to the press release.
Sacha Loiseau, CEO of Mauna Kea Technologies, said Cellvizio is currently available in more than 40 countries and Chinese regulatory approval strengthens the company’s footprint around the globe.
Cellvizio has received FDA clearance in the U.S. and CE Mark approval in European Union for use in the GI tract, biliary and pancreatic ducts and lungs, the company said.
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