News From CEO

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 will continue to maintain compliance as well as the adequacy and sustainability of our activities.

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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.
Features include the choroidal mode, which allows detailed evaluation of the choroid. A wide area scan of 9 mm x 9 mm ensures excellent overall coverage of the retinal structures. Microsaccades and other involuntary eye movements are compensated by the Tracing HD function during the macular line scans. This function ensures accurate alignment of up to 120 macular line scan images for enhanced image averaging. The automatic registration function compensates for cyclotorsion during image acquisition enhancing the quality of follow-up data.

High speed scanning of 53,000 A-scans/sec during acquisition with tracing increases accuracy as well as two additional higher sensitivity scanning modes with tracing that may enable imaging through media opacities.

The RS-3000 Advance can seamlessly integrate with most EMR systems using the NAVIS-EX image filing software, which networks the RS-3000 Advance and other NIDEK imaging devices.

Mr. Motoki Ozawa, President of NIDEK stated, “We are pleased to have this clearance, and confident the results reflect the quality of our diagnostic tools in imaging that assist doctors in diagnosing ocular diseases”.

About NIDEK:
Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.

For further information contact:
Keith Effert
Product Manager
Phone: 800.223.9044 – ext. 715
E-mail: keith_effert@nidek.com

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NIDEK CEM-530 Specular Microscope Receives 510K Clearance

cem 530NIDEK, 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.

Fremont, CA (PRWEB) February 05, 2014 — 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 that acquires images of the corneal endothelium and provides analysis very quickly and easily. The auto-tracking capabilities make acquisition speedy and straightforward.

Features include paracentral specular microscopy as well as peripheral images, two-second auto analysis, automatic indication of the optimal image, 3-D auto tracking, auto shot and a Tiltable touch screen and built-in printer.

The paracentral images are captured at eight points, at a 5° visual angle within a 0.25mm x 0.55mm field and enable enhanced assessment surrounding the central image.

Sixteen images are captured and automatically sorted based on quality. Once the best image is selected, complete analysis is automatically performed in two seconds with the CEM-530. The analysis screen allows visualization of the endothelial cells in four modes: trace, photo, area, and apex. This feature enables the clinician to verify analysis values with the corresponding cell images. The 3-D auto tracking, auto shot, and tiltable touch screen provide ease of use, allowing faster and more accurate measurement. An LED light source is utilized for illumination, which reduces power consumption, lasts longer, and saves on operational costs.

The CEM-530 can seamlessly integrate with most EMR systems without the need for an additional computer or software.

Mr. Motoki Ozawa, President of NIDEK stated, “We are pleased to have this clearance, and confident the results reflect the quality of our diagnostic tools in corneal referencing and early diagnosis of endothelial disease.”

About NIDEK
Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.

For further information, contact:
Ms. Polly Neely
Senior Marketing Manager
Phone: 800.223.9044 – ext. 762
E-mail: polly_neely@nidek.com

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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.

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. Measurement points of the topography-assisted LASIK are not restricted by the pupil diameter. The CATz treatment provides a customized unique correction for patients utilizing the NIDEK OPD-Scan measurement system together with the Final Fit software. Final Fit is NIDEK’s proprietary software that allows custom topography-assisted surgery.

Surgeons are finally able to treat myopic astigmatism with corneal irregularities with the CATz treatment. According to George O. Waring, III, MD, principal investigator of the US FDA Study, “the outcomes of the CATz study are astoundingly good – even with no individual center nomogram adjustment. One hundred thirty- three eyes evaluated from four centers at six months, showed improved visual acuity. More than 91% of patients were within ±0.5D of intended correction. Most excimer laser algorithms treating myopia and astigmatism increase higher order aberrations. In the conventional treatment, the RMS total higher order aberrations increases approximately 0.25 microns, but with topography-assisted LASIK, the increase was 0.08 microns.”

Mr. Motoki Ozawa, President of NIDEK stated, “We are pleased to have this approval, and confident the results reflect the quality of our laser. These results from 133 eyes demonstrate NIDEK’s commitment to providing an innovative, technologically superior excimer platform for laser vision correction surgery.
Furthermore, NIDEK is actively developing its own custom ablation and wavefront technology platform. The NAVEX Quest; EC-5000 Excimer Laser System is a perfect pairing to NIDEK’s strong, world-class product portfolio in unsurpassed diagnostic and surgical instrumentation, optical finishing and dispensing products for vision care.”

The following chart demonstrates the six-month follow up results of the safety and effectiveness of the Topography-Assisted LASIK clinical study:

Six Month Follow Up Results (133 Eyes): 49% 20/16 or better (UCVA)
89% 20/20 or better (UCVA) 95% 20/25 or better (UCVA)

About NIDEK:
Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.

For further information contact:
Ms. Polly Neely
Senior Marketing Manager
Phone: 510-353-7762
E-mail: polly_neely@nidek.com

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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. Plus, having the latest technology in place sends a message to patients about the culture of your facility: that you embrace changes that promise better results. With that in mind, here’s a look at 5 of the latest options for YAG, retinopathy and glaucoma procedures.

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

FOR IMMEDIATE RELEASE

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.

“The AFC-330 represents NIDEK’s 3rd generation of automated fundus camera. We are both proud and excited to be leading the way designing and producing fundus cameras that are faster, easier, and more versatile than ever. We anticipate increasing our fundus camera market share with our market expansion with MARCO Ophthalmic.”
Motoki Ozawa, President and CEO of NIDEK

“We couldn’t be more excited about adding the Nidek AFC-330 automated fundus camera to our full product line of diagnostic technologies. The AFC-330 fits perfectly into Marco’s successful model of increasing efficiency with the kind of powerful, easy-to-use, and high-quality instrumentation that our customers have come to expect.”
David Marco, President and CEO of MARCO

The AFC-330 makes quantum leaps improving the operator and patient interface, simplicity, automation, and total practice efficiencies. This camera offers an all in one compact design, auto alignment on the X-Y-Z axis, and a wide range of automated features including auto stereo for Glaucoma Management. The lower flash intensity and sound-dampening internal movements mean less retakes and improved patient comfort. No other Non-Mydriatic camera provides both this level of advanced automation and image quality.

While NIDEK will continue to sell to the Ophthalmology market in the United States, MARCO, the leader in Vision Diagnostics, will sell the NIDEK AFC-330 to the Optometry market. This market expansion is to increase the distribution channels and better serve new and existing customers for both companies.

About NIDEK:
Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.

About MARCO:
Founded in Jacksonville, FL, in 1967, MARCO continues to expand its position as ‘The Leader in Vision Diagnostics’ with a product line that encompasses classical lane equipment and NIDEK high-tech, automated refractive and retinal instrumentation.  MARCO continues to provide unparalleled training and support to its expanding United States customer base.

For More Information Contact:
NIDEK Inc.
Frank Wood, MBA
Marketing Manager
Phone: 800.223.9044 ext 762
E-mail: frank_wood@nidek.com


MARCO Ophthalmic
Michael J. Crocetta
Executive Director of Marketing
Phone: 800.874.5274 ext 160
E-mail: mcrocetta@marco.com


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