Koh Young Technology, a company specializing in semiconductor inspection equipment and robotics, announced on the 21st that it has received pre-market approval (510k) from the U.S. Food and Drug Administration (FDA) for a medical robot used in brain surgery. The 510k is an FDA certification system that demonstrates safety and efficacy that exceed equivalence to existing marketed devices.
The robot that received certification this time is the overseas version of the domestic robot 'KYMERO,' named 'Geniant Cranial.' It is utilized for surgeries and examinations of brain diseases and can be applied in various neurosurgical areas, including movement disorders such as epilepsy and Parkinson's disease, brain tumor biopsies, and surgeries for brain hemorrhages. It features the ability to accurately guide doctors to the location and path of the surgical site based on the patient's medical imaging.
Koh Young is the first domestic robotics company to receive FDA certification for brain surgery. Koh Young participated in a national project by the Ministry of Trade, Industry and Energy to develop a medical robot for brain surgery in-house. Since then, it has supplied a cumulative total of 10 units to domestic university hospitals, building a surgical history.
The company expects to fully enter the U.S. market with this certification. The U.S. is the world’s largest medical device market, and demand from medical professionals and patients for minimally invasive surgeries using robots is increasing. There are over 1,400 neurosurgery hospitals capable of performing brain surgeries.
A Koh Young official noted, "With FDA certification, we can sell the product immediately, which could significantly expand the company's performance through the medical robot business," adding, "We will also focus on the ongoing licensing in Japan to achieve successful overseas expansion results."