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TransEnterix Receives Japanese Regulatory Approval of Senhance

Posted on May 28, 2019 by Medtech[y] Staff


After announcing a rough first quarter earnings, TransEnterix was in need of some positive traction, which is what they received this morning after announcing Japanese regulatory approval for the Senhance Surgical System.

Japan is the second-largest medical device market in the world, valued at over $40 billion annually, including over $5 billion in capital equipment spending.

“Regulatory approval in Japan is a pivotal milestone for our company, as Japan is second only to the U.S. as the world’s largest surgical robotics market,” said Todd M. Pope, president and chief executive officer of TransEnterix. “Japan’s high penetration of laparoscopic surgery coupled with their rapid adoption of robotics and the intense focus on procedure cost creates a considerable market opportunity for Senhance.”

The Senhance Surgical System was approved (“Shonin”) by the Ministry of Health, Labor and Welfare (MHLW) for use in laparoscopy for general surgery, gynecology, urology and certain thoracic procedures.

"Approval of the Senhance Surgical System for use in laparoscopic procedures in Japan is a major achievement," said Professor Shigeki Yamaguchi, M.D., Ph.D., Chief of Colorectal Surgery at Saitama Medical University International Medical Center. "As the first hospital in Japan to obtain and utilize the Senhance Surgical System to treat patients, I believe this technology allows surgeons to offer excellent minimally invasive procedures that add precision and visual control while leveraging a familiar laparoscopic approach with minimal additional costs to the health system."

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