FDA clearance

This could eventually benefit OIL outside Neuro applications.

The addition of the indications for: “identification of cells and vessels and their organization or architecture” to the previously cleared intended use (the fields of gastroenterology¹, urology² and pulmonology³ during endoscopic, laparoscopic manual and robot-assisted surgical, and image-guided percutaneous procedures), 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 micro-vascular level during a wide variety of procedures in endoscopy and surgery,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies. “This milestone enables us to formally shift from imaging to identification, providing us with strong leverage to broaden adoption by healthcare providers and payers.”



https://www.businesswire.com/news/h...ance-Validates-Vivo-Real-Time-“Identification