News at NIDEK

Click Article Title to Read More.


NIDEK INC Takes on the Medmont E300 Corneal Topographer    06/27/2017

Medmont International Pty Ltd. and NIDEK Inc. are proud to announce its partnership as of May 25, 2017

NIDEK Inc. will now be offering the Medmont E300 Corneal Topographer to US Ophthalmologists, and Ophthalmic Government tendered competitions.

Read More


 

About ransomware attack                                 06/01/2017

 As reported in the media, ransomware* known as “Wanna Cryptor WannaCry”, “WannaCryptor”, or “Wcry” has caused damage to IT systems worldwide.

NIDEK is checking whether security update (MS17-010) provided by Microsoft can be applied to our products. The applicability of the security update will be determined and notified later.

*Ransomware: A type of malware. In Ransomware, computers infected by this virus are restricted from browsing files such as documents on infected terminals, so the victim is required to pay the ransom to the malware author in order to release the restriction. It is a ransom request type malicious program.


 

MP-3 Press Release

mp3-news

CLICK TO SEE PDF


 

GYC-500 Press Release

gyc5001

CLICK TO SEE PDF


CEM-530 Bulletin

2016-09-09_12-42-36

CLICK TO SEE PDF


News from CEO

President and CEO, Mr. Motoki Ozawa stated, The Food and Drug Administration has completed an evaluation of our firm’s corrective actions in response to its Warning Letter dated August 8, 2014. Based on their evaluation, the FDA confirmed that Nidek Inc. has addressed the issues contained in the Warning Letter and resulted in full resolution of this matter.


Nidek Innovation

NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has approved the use of the OPD-Scan III aberrometer and update the Final Fit software to facilitate compatibility with a new aberrometer to perform topography-assisted laser in-situ keratomileusis (LASIK)…..


News from CEO

We announced today that Nidek is cooperating fully with the Food and Drug Administration (FDA) to resolve the issues identified in the FDA’s August 2014 warning letter….


Nidek’s AL-Scan Optical Biometer Receives 510K Clearance

FREMONT, California, July 16, 2014
NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces that the United States Food & Drug Administration (FDA) has issued 510K clearance for it’s revolutionary new AL-Scan Optical Biometer that provides 6 essential values for cataract surgery very quickly. The auto tracking and auto shot capabilities make acquisition speedy and straightforward…..


NIDEK RS-3000 Advance Optical Coherence Tomographer receives 510K Clearance

FREMONT, California, March 19, 2014
NIDEK, Inc. a global leader in the design, manufacturing, and distribution of ophthalmic equipment, is pleased to announce FDA clearance of the RS-3000 Advance. This premier OCT system incorporating Scanning Laser Ophthalmoscope is designed for comprehensive evaluation of the retina and choroid. The RS-3000 Advance provides exquisite detail of the retinal and choroidal microstructures to assist in clinical diagnosis……


NIDEK CEM-530 Specular Microscope Receives 510K Clearance

NIDEK, a global leader in diagnostic and laser instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has issued 510K Clearance for its revolutionary new CEM-530 Specular Microscope…..


Topography-Assisted LASIK Approved by FDA

NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has approved its highly innovative Customized Aspheric Treatment Zone (CATz) for the NAVEX Quest; EC-5000 Excimer Laser System, one of the first topography-assisted LASIK procedure…..


Confocal infrared RM imaging of macular diseases

Click to read more….


What’s New in Ophthalmic Laser Treatment

The latest ophthalmic lasers have features that allow more accurate targeting inside the eye, which is safer in the hands of the surgeon and translates to better recovery for patients. Your facility may even benefit from decreased procedure times, which could let you see more patients in a day or just give your staff and physicians a little breathing room to spend a little extra time with patients and their caregivers.


NIDEK And Marco Announce FDA 510(k) Clearance For The AFC-330 – Automated Fundus Camera

FREMONT, Calif. and JACKSONVILLE, Fla., May 15, 2012 ” NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces the FDA 510(k) Clearance for the AFC-330, their most automated fundus camera yet.


NIDEK ANNOUNCES ENHANCED ALLIANCE WITH MARCO OPHTHALMIC BY EXPANDING THE SALES DISTRIBUTION CHANNELS OF NEW FUNDUS CAMERA

FREMONT, Calif. and JACKSONVILLE, Fla., February 27, 2012
NIDEK announces a market expansion of the their fundus camera distribution by granting MARCO Ophthalmic exclusive rights to sell NIDEK’s newest fundus camera to the optometry market. NIDEK Inc. will continue to provide sales and service to the Ophthalmology market, as well as service to their existing customers. NIDEK is currently pursuing FDA clearance for its newest fundus camera. Joint distribution of the product will begin once FDA clearance is obtained.



Part # 15-0068