Diabetes: FDA warns Dexcom on adverse event reports
March 25, 2014 by Brad Perriello
Japanese Ministry of Health
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.
Covidien lands Japanese approval for surgical staples
Zoll wins Japanese approval for monitor/defibrillator hybrid
Zoll Medical (NSDQ:Zoll) won Shonin approval from Japan’s Ministry of Health, Labour & Welfare for its X Series monitor/defibrillator system.
Gore wins Japanese approval for Excluder endoprosthesis
W.L. Gore & Associates said it won Shonin approval from the Japanese Ministry of Health, Labor & Welfare to market its Excluder AAA endoprosthesis with C3 delivery system for treatment of abdominal aortic aneurysms.
Medtech regulatory reform advances in Japan
By Stewart Eisenhart, Emergo Group
Legal reforms affecting medical device regulation in Japan have passed the country’s Diet and are now published in the official Japanese gazette, bringing them closer to full enactment in Asia’s largest single medical device market.
Lumenis wins U.S. & Japanese clearance for retinal laser treatment
Lumenis Ltd. announced today regulatory wins in the U.S. and Japan for its Array LaserLink pattern scanning device for multi-spot laser photocoagulation for use during retinal surgery.
The Array LaserLink, which turns an "examination slit lamp" into a medical laser, expands on the Lumenis laser system to deliver “pattern scanning capabilities, aimed to provide greater predictability in retinal treatments and presumably less collateral damage to the retina,” according to a press release.
Stereotaxis jumps on Japanese reimbursement win, releases Q3 prelims
Stereotaxis won Japan’s highest reimbursement classification for its Niobe magnetic navigation system.
The Niobe system is now classified as a C2 medical device by Japan’s Ministry of Health, Labor & Welfare, according to a press release.
