Covidien has announced that its Japanese subsidiary, Covidien Japan, received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA reinforced reload with Tri-Staple technology. This approval extends ...
Tags: Covidien, Tri-Staple technology, Endo GIA
Asahi Kasei Zoll Medical, the Japanese subsidiary of Zoll Medical, has obtained Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its X Series monitor/defibrillator, designed primarily for emergency medical ...
Jarvik Heart, a manufacturer of cardiac assist devices, has announced the Shonin approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the Jarvik 2000 heart, a small left ventricular assist device implanted inside ...
W. L. Gore & Associates, Inc. (Gore) has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the GORE EXCLUDER AAA endoprosthesis featuring C3 Delivery System as a minimally invasive treatment for ...
Century Medical, the Japanese partner of TriReme Medical, has obtained Shonin approval for the GliderXtreme PTA catheter, which is designed for the treatment of peripheral arterial blockages. GliderXtreme has a low-profile nitinol shaft ...
Tags: Century Medical, PTA Catheter
PLC Systems, a medical device company, has obtained an approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to initiate a single-arm clinical trial in Japan using its RenalGuard therapy. This approval is based on MHLW's ...
Tags: PLC Systems, Renalguard Therapy
NuVasive, a medical device company, has announced the first surgeries in Japan using its Precept system, a minimally disruptive posterior fixation solution to patients. The Precept system offers the most advanced technologies in guide ...
Tags: medical device, NuVasive
TriReme Medical's Japanese partner Century Medical has received Shonin approval for the Glider PTCA catheter, which is used to treat the stenotic portion of coronary arteries or bypass grafts to improve the myocardial perfusion. Used ...
Tags: Glider PTCA Catheter, Medicine
Zoll Medical has gained Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its intravascular temperature management (IVTM) system, designed for use in neurologically injured patients to control fever. The ...
Tags: Medical, care decices, clinical trial
The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems. Pegasus, an anchored anterior cervical interbody device, offers single-step deployment ...
Tags: MIS Systems, Alphatec, FDA Approval, New Anterior Cervical Interbody
Cosmotec, a distribution partner of Endologix in Japan, has obtained Shonin approval from Japanese Ministry of Health, Labor and Welfare (MHLW) for its IntuiTrak Delivery system. Featuring a simplified deployment mechanism and hydrophilic ...
Tags: Cosmotec, Endologix, Japan, Shonin approval, MHLW