First Domestic Technology... Second Approval by FDA

VPIX Medical, a specialist in real-time digital biopsy devices for cancer surgery, announced on the 29th that it has received pre-market approval (510k) from the U.S.
FDA for its "cCeLL-In vivo." This device provides real-time digital imaging at the cellular level during surgery without invasive biopsies.
Based on miniature confocal microscopy technology, it allows surgeons to visualize brain tumors and microstructures in real-time, offering enhanced precision for tumor removal and protection of healthy brain tissue.

By using indocyanine green (ICG) dye, the device delivers high-resolution fluorescence microscopy images. VPIX Medical, recognized for its technology, developed the first domestic miniature fluorescence microscope for cancer surgery.
This approval marks the second case globally for ICG fluorescence imaging microscopes to receive FDA certification.

With no prior FDA-certified ICG fluorescence microscopes in neurosurgery, this Korean medical device is expected to become a new industry standard.

Hwang Kyung-min, CEO of VPIX Medical, said, “This FDA approval provides neurosurgeons with a powerful tool for making real-time decisions during surgery.”
She also emphasized the significance of gaining FDA recognition for the safety and effectiveness of their product in the U.S., the largest medical device market.

From this year, VPIX Medical has initiated clinical research with brain tumor patients at Korea University Anam Hospital, Seoul National University Hospital, Samsung Medical Center, and Boramae Medical Center.
With FDA approval, they plan to expand these trials internationally and aim for a broader entry into the global market.

Original article: https://www.hankyung.com/article/202408294185i