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Japanese Ministry of Health

Japan approves expanded reimbursement coverage for Abbott’s FreeStyle Libre CGM

March 24, 2022 By Sean Whooley

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, […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Regulatory/Compliance Tagged With: Abbott, Japanese Ministry of Health, Reimbursement

J&J Vision wins Japanese approval for first drug-releasing contact lens

March 25, 2021 By Sean Whooley

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 […]

Filed Under: Drug-Device Combinations, Featured, Optical/Ophthalmic, Regulatory/Compliance Tagged With: Japanese Ministry of Health, Johnson & Johnson

TransEnterix wins Japanese OK for Senhance in robot-assisted surgery

May 28, 2019 By Brad Perriello

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 […]

Filed Under: Featured, Regulatory/Compliance, Surgical, Surgical Robotics, Wall Street Beat Tagged With: Japanese Ministry of Health, TransEnterix

Japan approves market return for NuVasive’s XLIF spinal fusion

December 29, 2016 By Brad Perriello

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 […]

Filed Under: Regulatory/Compliance, Spine Tagged With: Japanese Ministry of Health, Nuvasive

Glaukos wins Japanese nod for iStent glaucoma device

March 28, 2016 By Brad Perriello

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 […]

Filed Under: Optical/Ophthalmic, Regulatory/Compliance Tagged With: Glaukos, Japanese Ministry of Health

Japan approves the Sapien 3 heart valve from Edwards Lifesciences

March 16, 2016 By Brad Perriello

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 […]

Filed Under: Regulatory/Compliance, Replacement Heart Valves Tagged With: Edwards Lifesciences, Japanese Ministry of Health

STJ pushes ‘play’ on Portico | Regulatory news for the week of March 16, 2015

March 17, 2015 By MassDevice Contributors Network Leave a Comment

St. Jude Medical pushes 'play' on Portico TAVI device

March 12, 2015 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Boston Scientific, Japanese Ministry of Health, lombardmedical, Medico's Hirata Inc., stjudemedical, Tornier Inc.

Japan approves Lombard Medical’s AorFlex delivery device

March 13, 2015 By Brad Perriello Leave a Comment

Lombard Medical's Aorfix stent graft wins nod in Japan

Filed Under: News Well, Regulatory/Compliance, Stent Grafts Tagged With: Exports, Japanese Ministry of Health, lombardmedical, Medico's Hirata Inc.

Medtronic wins nod in Japan for Evera MRI-safe ICD

November 10, 2014 By Brad Perriello Leave a Comment

Medtronic wins nod in Japan for Evera MRI-safe ICD

Medtronic (NYSE:MDT) said it won approval from Japan’s Ministry of Health, Labor and Welfare for its Evera MRI SureScan implantable cardiac defibrillator for use in full-body MRI scans.

Filed Under: News Well, Regulatory/Compliance Tagged With: Cardiac Rhythm Management, Exports, Japanese Ministry of Health

Zoll lands Japanese OK for R Series monitor/defibrillator

July 31, 2014 By Brad Perriello Leave a Comment

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: Asahi Kasei Corp., Exports, Japanese Ministry of Health, Resuscitation, Zoll Medical

Promus Premier stent debuts in Japan

May 1, 2014 By Arezu Sarvestani

Boston Scientific launches Promus Premier stent in Japan

Medtech titan Boston Scientific (NYSE:BSX) has launched commercial efforts after landing Japanese regulatory approval for its Promus Premier drug-eluting stent.

Filed Under: Drug-Eluting Stents, News Well, Regulatory/Compliance, Stents Tagged With: Boston Scientific, Japanese Ministry of Health

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