Dec. 21, 2017—Mauna Kea Technologies received expanded FDA 510(k) clearance for the Cellvizio 100 series confocal laser microscope and its Confocal Miniprobes. The expanded clearance adds indications for identification of cells and vessels and their organization or architecture. The previously cleared intended use included the fields of gastroenterology, urology, and pulmonology during endoscopic, laparoscopic manual and robot-assisted surgical, and image-guided percutaneous procedures.
The company said the new clearance represents a pivotal milestone for in vivo real-time microscopic visualization technology.
“With this new clearance, Cellvizio is affirmed as the only platform for imaging and identification at the cellular and microvascular level during a wide variety of procedures in endoscopy and surgery,” Sacha Loiseau, PhD, founder and CEO of Mauna Kea Technologies, said in a statement. “This milestone enables us to formally shift from imaging to identification, providing us with strong leverage to broaden adoption by healthcare providers and payers.”