Japanese regulators approved the Senhance robot-assisted surgery device made by TransEnterix (NYSE:TRXC) for several procedures, the company said today. Japan’s Ministry of Health, Labor & Welfare granted “shonin” approval to Senhance for laparoscopy for general surgery, gynecology, urology and “certain thoracic procedures,” the Research Triangle Park, N.C.-based company said. “Regulatory approval in Japan is a pivotal milestone […]
Japanese Ministry of Health
Japan approves market return for NuVasive’s XLIF spinal fusion
NuVasive Inc. (NSDQ:NUVA) said today that it won approval from the Japanese Ministry of Health, Labor & Welfare for the return of instruments used in its eXtreme lateral interbody fusion procedure to the market in Japan. San Diego-based NuVasive said instruments and components used in lateral access procedures are Class III devices in Japan, despite the fact that […]
Glaukos wins Japanese nod for iStent glaucoma device
Glaukos (NYSE:GKOS) said today that the Japanese Ministry of Health, Labor & Welfare approved its iStent device for treating glaucoma. Laguna Hills, Calif.-based Glaukos said the approval covers use of the iStent in conjunction with cataract surgery, making it the 1st within-the-eye micro-invasive glaucoma surgery device to hit the market in Japan. The device is designed to be […]
Japan approves the Sapien 3 heart valve from Edwards Lifesciences
Edwards Lifesciences (NYSE:EW) said today that the Japanese Ministry of Health, Labor & Welfare approved its Sapien 3 transcatheter aortic valve replacement. Irvine, Calif.-based Edwards said it expects to win reimbursement approval in Japan during the 2nd quarter and launch “immediately thereafter” with a full rollout complete by the end of the year. “We are pleased to be […]
STJ pushes ‘play’ on Portico | Regulatory news for the week of March 16, 2015
Japan approves Lombard Medical’s AorFlex delivery device
Medtronic wins nod in Japan for Evera MRI-safe ICD
Zoll lands Japanese OK for R Series monitor/defibrillator
Zoll Medical said today that it won Shonin approval from the Japanese Ministry of Health, Labor & Welfare for its R Series combination monitor and automated external defibrillator.
Promus Premier stent debuts in Japan
Medtech titan Boston Scientific (NYSE:BSX) has launched commercial efforts after landing Japanese regulatory approval for its Promus Premier drug-eluting stent.
FDA flags Dexcom on reporting compliance | Medtech regulatory news for the week of Mar. 31, 2014
Japanese regulators plan faster medical device registration process
By Stewart Eisenhart, Emergo Group
A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned changes to the country’s medical device market regulatory system.
