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FDA clears Mauna Kea AQ-Flex19 miniprobe

Mauna Kea Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AQ-Flex 19 miniprobe.

AQ-Flex 19 miniprobe is used to provide real-time optical biopsies during endoscopic ultrasound-guided fine needle aspiration (EUSFNA) procedures in the digestive tract.

The University of California Irvine School of Medicine H.H. Chao Comprehensive Digestive Disease Center executive director Kenneth Chang said that the needle-based optical biopsies may provide the missing information needed to separate the high risk versus low risk cysts and impact patient management.

Mauna Kea Technologies CEO Sacha Loiseau said that the AQ-Flex 19 miniprobe, at only 0.8 mm in diameter, exemplifies the company’s dedication to consistent innovation of optical biopsy technology.

"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," Loiseau added.

The AQ-Flex miniprobe is compatible with Cellvizio 100 series systems currently marketed by Mauna Kea Technologies.