iBeam Technology Obtains Medical Device Manufacturing Certification for "Robotic Arm Two-Photon Bio-Microscope"

High-Resolution Cellular Imaging During Surgery Without Tissue Excision

Expanding Applications to Head and Neck Cancer and Breast Cancer

iBeam Technology, a leading company specializing in advanced bio-imaging, announced on August 24 that it has obtained GMP compliance certification, a medical device manufacturing license, and Class II medical device manufacturing certification for its "Mobile Robotic Arm Two-Photon Bio-Microscope (IVM-RMS)," which allows real-time observation of cancer tissues during surgery.

Robot arm light beam bio microscope equipment by Ibeam Technology. Ibeam Technology

This device has been classified as a Class II medical fluorescence imaging device by the Ministry of Food and Drug Safety. It is a mobile system equipped with a collaborative robotic arm, enabling real-time, high-resolution cellular imaging during surgery without tissue excision. The system can automatically correct for subtle tissue movements, ensuring the acquisition of stable images.

iBeam Technology plans to integrate AI-based cancer diagnosis support software with its system and conduct proof-of-concept clinical trials to build AI cancer diagnosis models in vivo. Currently, multicenter clinical performance trials linking the two-photon microscope for in vitro diagnostics with AI cancer diagnostic assistant software are underway at Seoul National University Bundang Hospital, Korea University Anam Hospital, and Seoul National University Hospital.

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