[Source: Ministry of Food and Drug Safety]
South Korea’s Ministry of Food and Drug Safety said Tuesday it has granted the country’s 10th innovative medical device designation to Meere Company’s automated surgical robot which is used for laparoscopic surgery of gallbladder, prostate and other nearby body parts.
Laparoscopic surgery is a method by which surgery is performed through small incisions in the abdominal wall. The procedure will be visualized with the help of a camera, which is inserted through the incisions.
Under the medical device industry law, medical devices with the designation are given a priority in regulatory review for marketing approval or eligibility for fast-track review.
This medical product is an automated laparoscopic surgery robot developed for the first time in Korea and the second in the world and has been recognized for its innovativeness as a product with advanced medical robot technology.
It is also the first designation in the class of medical robot technology.
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