Abbott (NYSE:ABT) announced today that it received expanded reimbursement coverage in Japan for the FreeStyle Libre system. Japan’s Ministry of Health, Labour and Welfare approved the expansion for the continuous glucose monitoring (CGM) system to include all people with diabetes who use insulin at least once per day. Get the full story at our sister site, […]
Japanese Ministry of Health
J&J Vision wins Japanese approval for first drug-releasing contact lens
Johnson & Johnson Vision announced that it received approval in Japan for its Acuvue Theravision lens with Ketotifen. The company touts the lens as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery, according to a news release. Get the full story at our sister site, Drug Delivery Business […]
TransEnterix wins Japanese OK for Senhance in robot-assisted surgery
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 […]
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.
