French medical device firm Mauna Kea Technologies has received the US Food and Drug Administration (FDA) 510(k) approval, along with the CE Mark approval for its advanced Cellvizio platform.
The company said that Cellvizio is a multidisciplinary probe- and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform, designed using its advanced system architecture, and the regulatory approval marks the 18th FDA 510(k) approval for the Cellvizio platform.
Mauna Kea Technologies chief executive officer Robert L Gershon said: “We are proud to announce the FDA clearance and CE marking of our next generation Cellvizio in the USA and in Europe.
“The next generation Cellvizio platform will be launched commercially in the coming months and, with its modular and flexible design as well as being AI and molecular imaging ready, will host our future innovations, indications and support partnership developments.”
Cellvizio will integrate with advanced laparoscopic, navigation, and robotic systems
The Cellvizio platform is said to incorporate advanced modular design solutions to better integrate endomicroscopy within procedure suites, along with third-party platforms.
The company said that it has designed the hardware and software of the new platform to facilitate future developments, including integration of deep learning capabilities including artificial intelligence (AI) for assisted image interpretation.
The ergonomic and reduced footprint of the platform will easily integrate with advanced laparoscopic, navigation, and robotic systems.
In addition, the platform would also host other novel endomicroscopic architectures, which support fluorescence-guided surgery and molecular diagnosis, through imaging capabilities at different wavelengths.
Mauna Kea said that its new platform will offer smart workflows through its completely redesigned user interface, including new touchscreen and single-handed probe connection.
In addition, the platform will deliver advanced imaging capabilities, and brings precision imaging to more patients with 9 dedicated Confocal Miniprobes. It provides clinicians with high-performing, imaging solution for endoscopy, interventional, and surgical operating suites.
