Korea Biomedical Review – LivsMed has applied for Korean regulatory approval of its STARK surgical robot, taking a key step toward expanding its minimally invasive surgery portfolio into robot-assisted procedures. The Kosdaq-listed medical device maker said it submitted an application for product approval to the Ministry of Food and Drug Safety (MFDS) and aims to secure approval by the end of this year.
STARK was developed in Korea using LivsMed’s proprietary surgical instrument technologies, including the articulation technology behind its flagship ArtiSential handheld laparoscopic instruments. ArtiSential uses multi-jointed instruments that move in sync with a surgeon’s hand and wrist movements, allowing them to reach angles that are difficult to access with conventional straight laparoscopic tools. LivsMed said ArtiSential has been used in more than 300,000 surgical procedures in Korea and overseas.
The company has extended the technology to STARK, whose robotic instruments can articulate up to 90 degrees in multiple directions inside the body. LivsMed said the design is intended to provide greater flexibility and access during surgery. The robotic arm system also uses a compact modular structure designed to fit into existing operating rooms without requiring major changes to their layout.
In Korea, the company currently offers ArtiSential, the ArtiSeal vessel sealing system, the ArtiStapler surgical stapler and the LivsCAM laparoscopic camera system. With STARK, LivsMed is seeking to cover both handheld laparoscopic instruments and robot-assisted surgery within a single product portfolio. LivsMed said obtaining Korean approval for STARK would complete the domestic regulatory lineup covering its conventional laparoscopic instruments, advanced articulating devices and surgical robot platform.
STARK made its Korean debut in May and was later presented at the Society of Robotic Surgery 2026 (SRS 2026) in Florida in July, where surgeons discussed the platform’s design and preclinical testing experience.
“Technology becomes innovation only when everyone can benefit from it,” LivsMed CEO Lee Jung-joo said. “The company aims to make STARK competitive not only through its surgical capabilities but also through pricing, as we seek to make robot-assisted surgery accessible to a wider range of hospitals.”
About LivsMed
LivsMed develops surgical solutions for minimally invasive procedures, collaborating with physicians worldwide to improve patient outcomes and expand access to advanced surgical capabilities. The company is headquartered in Seoul, Republic of Korea, and maintains a U.S. subsidiary in San Diego, California.
* LivsMed’s STARK™ RAS system is not approved for use and not for sale.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws in Korea. Forward-looking statements include, but are not limited to, statements regarding the company’s business strategy, product development, regulatory approvals, clinical and commercial timelines, international expansion, market opportunities, financial performance, and future growth prospects.
These statements are based on management’s current expectations, assumptions, and information available as of the date of this release and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, changes in global market conditions, regulatory approval processes and requirements in Korea, the United States, and other international markets, reimbursement policies, clinical outcomes, manufacturing and supply-chain considerations, competitive dynamics, intellectual property protection, and foreign exchange fluctuations.
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Contacts
Media Contact
LivsMed U.S. Communications
Email: [email protected]
Phone: (949) 415-5554
