Mauna Kea Technologies (ENT:MKEA) landed FDA clearance for its AQ-Flex 19 mini-probe, which is already on the market in Europe. The device is designed to biopsy pancreatic cysts during endoscopic needle aspiration procedures in the digestive tract.
The Paris, France-based company touted its 6th U.S. regulatory clearance and plans to make the AQ-Flex 19 immediately available alongside its Cellvizio 100 cancer diagnostic system already on the market, according to a press release.
"This U.S. regulatory clearance represents a significant business milestone for the company and extends the application of optical biopsies into new clinical areas only reachable with fine needles where there is a significant unmet medical need for more efficient and accurate diagnoses," said CEO Sacha Loiseau in prepared remarks. "The AQ-Flex 19 mini-probe, at only 0.8 mm in diameter, exemplifies Mauna Kea Technologies’ dedication to consistent innovation of optical biopsy technology."
The Cellvizio system has received FDA clearance in the U.S., CE Mark approval in European Union and regulatory approval in China for use in the GI tract, biliary and pancreatic ducts and lungs.