VPIX Medical Achieves FDA Approval for Medical Device"If you connect this probe (controller) to the main device, medical staff can check the necessary area via video," explained Hwang Kyung-min, CEO of VPIX Medical, during a demonstration of their newly developed medical device at their headquarters in Daejeon on the 3rd. When connecting the pen-like probe to the desktop-like main device, it allowed for real-time visualization of brain tumors, blood vessels, and microstructures without injections or surgery. On the same day at Tomocube’s Daejeon headquarters, Chief Technology Officer (and KAIST professor) Park Yong-geun demonstrated video footage clearly showing the movement of cells.

The evolution of the microscope, a tool that almost every adult has used during their school years, is advancing rapidly. While microscopes previously only magnified samples, recent developments in artificial intelligence (AI) and optical (laser and light) technology now enable non-invasive (non-skin penetrating) applications for disease treatment, drug development, and defect detection in semiconductor processes.

A New Era for Precisely Targeting and Removing Cancer Cells

VPIX Medical, a digital biopsy medical device company specializing in cancer surgeries, received FDA approval on the 21st of last month for their self-developed device, “cCeLL-In vivo.” By incorporating confocal microscopy technology, which uses light that aligns with the focus of the sample, they reduced the size of traditional desk-sized microscopes to desktop-sized, improving mobility. Additionally, the resolution has been enhanced to allow the identification of cells as small as one-fifteenth the thickness of a human hair, making it applicable for brain tumor treatments.

In the past, cancer surgeries involved removing entire healthy organs to ensure the removal of cancer cells, which posed significant risks to the patient. More recently, minimal removal has been pursued for patient safety, but confirming cancer cells during surgery still required a 20-30 minute process of sending tissue to pathology. Even then, the accuracy was only around 80%. This method posed burdens for both the operating medical staff and the patient, with concerns about potential nerve cell damage, and lacked precision in determining malignancy.

To address this, VPIX Medical introduced indocyanine green (ICG) dye, a clinically-proven safe substance, injected into the body. This allows their device to visualize brain tumors and microstructures of brain blood vessels by transmitting a laser through the body. Hwang Kyung-min, CEO and a KAIST graduate, explained, “Cancer patients need accurate identification of cancer cells for surgery, and they deserve the right to choose between removal or drug treatment depending on the malignancy. Since patients can't move to the microscope, we implemented the concept of bringing the microscope to the patient.”

He further explained that the medical device can be customized for different types of cancers. “We’ve already secured technology that can be applied to various cancers. We plan to enter the U.S., the largest medical device market, with the approved device and expand its application beyond brain tumors to other types of cancers,” Hwang said.


Original article: https://www.msn.com/ko-kr/health/other/%ED%98%84%EB%AF%B8%EA%B2%BD%EC%9D%98-%EC%A7%84%ED%99%94-%EC%95%94%EC%84%B8%ED%8F%AC%EB%A7%8C-%EC%BD%95-%EC%A7%91%EC%96%B4-%EC%A0%88%EC%A0%9C-%EA%B0%80%EB%8A%A5%ED%95%B4%EC%A7%84%EB%8B%A4/ar-AA1q0shA?apiversion=v2&noservercache=1&domshim=1&renderwebcomponents=1&wcseo=1&batchservertelemetry=1&noservertelemetry=1&ocid=socialshare