‘cCeLL - In vivo with Drop-In Robo’
Also Obtains a Class II Medical Device Licence from Health Canada
Robotic Surgery Product Line Clears Key Regulatory Milestones in North America

VPIX Medical, a medical device company specializing in real-time digital biopsy solutions for cancer surgery, announced that its robotic surgery digital biopsy platform, ‘cCeLL - In vivo with Drop-In Robo,’ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and has also obtained a Class II Medical Device Licence from Health Canada.

The newly FDA-cleared ‘cCeLL - In vivo with Drop-In Robo’ is an ultra-compact microscope incorporating VPIX Medical’s core technologies. The system adopts a Drop-In approach, in which the device is attached to a surgical robot arm and inserted directly into the abdominal cavity. By digitally capturing cellular-level images of target lesions in real time during surgery, the platform enables surgeons to immediately assess the surgical margin and make more precise clinical decisions.

This milestone is particularly significant as it expands the platform capabilities of ‘cCeLL - In vivo,’ which has already demonstrated its technological value as a real-time digital biopsy device in brain tumor surgery, into the field of robotic surgery. With both its neurosurgery and robotic surgery product lines meeting key North American regulatory requirements, VPIX Medical has further strengthened its portfolio in the digital biopsy market.

The company has also obtained a Class II Medical Device Licence from Health Canada, further strengthening its foundation for entry into the North American market. The Health Canada licence covers the main system as well as PROBE configurations (Pixection Neuro and Drop-In Robo), expanding the range of applications within robotic surgery workflows used in clinical practice.

VPIX Medical plans to begin with prostate cancer, where demand for robotic surgery is particularly high, and gradually expand the platform’s applications to robotic procedures involving the bladder, stomach, lungs, and other organs, further enhancing its clinical value in the operating room.

Kyungmin Hwang, CEO of VPIX Medical, said, “This FDA 510(k) clearance marks an important milestone in expanding cCeLL’s technology, which has already demonstrated its value in brain tumor surgery, into the robotic surgery market.” He added, “We expect that expanding into additional indications will significantly reduce the time required for regulatory procedures and market entry.”

Meanwhile, building on its clinical experience and achievements in brain tumor surgery in Korea and overseas, VPIX Medical began clinical research at Seoul National University Hospital, Samsung Medical Center, and Korea University Anam Hospital in the second half of last year. This year, the company plans to expand its clinical research involving prostate cancer patients to include Asan Medical Center. Based on the FDA 510(k) clearance and Health Canada Class II Medical Device Licence, VPIX Medical plans to accelerate its expansion into the global medical device market, including North America.

VPIX Medical is a medical device company that develops and manufactures cCeLL, a Digital Biopsy Platform that provides real-time, cellular-level imaging of target lesions during cancer surgery. The platform enables clinicians to rapidly assess the presence of residual cancer cells and supports faster clinical decision-making.

Jiho Choi, Reporter (jhochoi51@irobotnews.com)

The Robot News (April 10, 2026)

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