Mauna Kea Technologies Awarded 510(k) Clearance for Use of Cellvizio in Surgery

The FDA has granted 510(k) clearance to Mauna Kea Technologies for use of its Cellvizio in surgery.

Cellvizio, a multidisciplinary confocal laser endomicroscopy platform, provides a real time microscopic image of tissue during a surgical procedure, enabling surgeons to identify cancerous tissue and guide treatment.

Using Cellvizio, surgeons may be better able to confirm the absence or presence of metastasis that may not be visible using preoperative imaging, the Suwanee, Ga.-based company says.

The platform is being studied in several major clinical trials in surgical treatment of cancer. — Michael Cipriano