Korean medical robotics company Koh Young Technology said Monday that it has received 510(k) clearance from the U.S. FDA for its brain surgery robot Geniant Cranial.

The device, an upgraded global version of Koh Young’s neurosurgical robot KYMERO, is a stereotactic robotic guidance system that uses medical imaging to support complex procedures, including surgeries for epilepsy and Parkinson’s disease, brain tumor biopsies, and intracerebral hemorrhage operations.

A company official said Geniant Cranial offers enhanced user experience, improved ease of operation, and greater accuracy compared to its predecessor.

KYMERO was developed through a national initiative led by Korea’s Ministry of Trade, Industry and Energy and has been adopted by nine Korean hospitals, including Seoul National University Hospital, Samsung Medical Center, and Severance Hospital.

With FDA clearance, Koh Young is gearing up to enter the U.S. market, which is the largest for medical devices globally.

The company official noted that demand for minimally invasive robotic surgeries is growing among healthcare professionals and patients in the U.S., where over 1,400 neurosurgical hospitals represent significant market potential.

According to Transparency Market Research, the global robotic surgery market is projected to grow from $7.9 billion in 2022 to $20.8 billion by 2031, driven by advances in robotic technology and increasing demand for precision medicine across neurosurgery, orthopedics, and general surgery.

Koh Young is also pursuing regulatory approval in Japan as part of its broader international expansion strategy. “With FDA clearance, we can immediately proceed with sales, which is expected to significantly boost our performance,” the company official said.

출처 : KBR(https://www.koreabiomed.com)