Japan
Medical device market intelligence for Japan. Regulatory changes, competitor moves, and procurement trends.
Recent signals
MENICON CO. LTD. has registered product code HQD with the FDA, listing one medical device.
Everx Japan Co. Ltd has registered a medical device with product code IZI under FDA registration 3014343100.
J&J's Shockwave C2 Aero IVL device offers faster treatment for complex calcifications, FDA approved in June 2025.
NIKKISO CO., LTD. has registered with the FDA under product code PBN, listing one product.
Japan Optical Co., Ltd. has registered a medical device with product code HOI under FDA registration 8030369.
Olympus Corporation has registered three medical devices under product code IYN with the FDA.
Study assessed thrombus aspiration and distal protection devices in ACS patients at high risk for embolism.
The TRISCEND JAPAN study evaluates the Edwards EWJ-202 valve system for severe tricuspid regurgitation treatment.
YAMAKIN CO., LTD. registered ZEO CE LIGHT Opaque VO A3.5 50g Powder as a Class IIa medical device.
OLYMPUS CORPORATION has registered a medical device with product code FGE in the FDA database.
The SPIRIT III trial compared XIENCE V® stents to TAXUS® EXPRESS2™ in the US and Japan, focusing on various diameters.
The RIVER JAPAN study confirms the safety and efficacy of the Rev-01 thrombectomy catheter for acute ischemic stroke.
Global health regulation is becoming less predictable, impacting trust in medicines and medical devices.
Home-based neuromodulation shows promise for managing ventricular arrhythmias, with positive results from Japan.
Olympus has partnered with EndoRobotics for global distribution of robot-assisted endoscopic technologies.
The Hot AXIOS System post-market survey in Japan aimed to identify adverse events and device malfunctions.
M.D. Japan, LTD is registered with the FDA under product code NNI, listing one product.
MENICON CO. LTD. has registered two medical devices with the FDA under product code NUU.
TSK Laboratory International Japan KK is registered with the FDA under product code QYM.
The Disposable Electrode V-04PO4 by Nihon Kohden is registered as a Class I medical device.