NIDEK INC Takes on the Medmont E300 Corneal Topographer

June 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.

“This is a great opportunity for both Medmont and NIDEK Inc., as it allows Medmont to have an established and well-respected partner in the Ophthalmology space, but at the same time allows NIDEK Inc. to add a world class topographer to their already great portfolio of instruments”. Robert Heavyside, President of Medmont

“It was an easy decision for NIDEK Inc. to partner with Medmont and to go with the E300 Topographer. We were impressed by the instruments ability to capture from limbus to limbus, plus having a non-invasive and accurate way of detecting dry eye was a big plus too. NIDEK Inc. is happy to be able to offer this instrument to MD’s in the United States”. Motoki Ozawa, President and CEO of NIDEK Inc.

If you are interested in learning more about the E300 Corneal topographer from a NIDEK Inc. representative please contact Senior Product Marketing Manager Keith Effert at keith_effert@nidek.com

About Medmont

Medmont is a global leader in the manufacturing of software and equipment for the ophthalmic market. The company was founded in 1988 and is based in Melbourne, Australia. Medmont’s product range consists of the: E300 Corneal Topographer, M700 Automated Perimeter, DV2000 Diagnostic Imaging Software, and the AT20P Acuity Tester.

You can reach Medmont or one our global distributors at www.medmont.com/contact

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.

Contact:

NIDEK Inc.

info@nidek.com

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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 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).

Mr. Motoki Ozawa, President of NIDEK stated, “We are pleased to have this approval, and confident the results reflect the quality of our products.”

This demonstrates NIDEK’s commitment to providing an innovative, technologically superior excimer platform for laser vision correction surgery. Furthermore, NIDEK’s NAVEX Quest; EC-5000 Excimer Laser System is a perfect pairing to our strong, world-class product portfolio in unsurpassed diagnostic, surgical instrumentation, optical finishing and dispensing products for vision care.

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:
Ron Kaiser
Director of Sales & Marketing
Phone: 800-223-9044– ext. 713
E-mail: ron_kaiser@nidek.com

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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.

President and CEO, Mr. Motoki Ozawa stated, “our response describing our corrective actions will be filed in a timely manner to the FDA. NIDEK is taking action to address the issues adequately and expeditiously to ensure full compliance with FDA requirements. We expect that our corrective actions will result in full resolution of this matter and we will continue to fulfill our role in providing eye care solutions.”

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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 its 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.

The AL-Scan measures 6 fundamental values for cataract surgery in 10 seconds. These values are, axial length, corneal curvature radius, anterior chamber depth, central corneal thickness, white-to-white distance, and pupil size. The rapid measurement enhances clinical efficiency and patient comfort. The AL-Scan incorporates 3-D auto tracking and auto shot, which provides the operator with the most ease, comfort, and accuracy on all measurements.

Nine IOL calculation formulas including Shammas PL for post-LASIK eyes are incorporated in the AL-Scan. Once measurement is completed, the IOL power is automatically calculated using its own measured data. The AL-Scan can optimize the IOL constants by statistically calculating with the postoperative refractive power. For toric IOL implants, a digital protractor is included to determine the angle between the steepest corneal meridian and the line passing through a landmark such a prominent vessel. The image of the eye with an overlay of the digital protractor can be used in the operating room for accurate alignment of toric IOLs. The AL-Scan represents a fundamental instrument for ophthalmic surgeons.

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 measurements that assist doctors in pre/post operative evaluations.

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:
Ron Kaiser
Director of Sales & Marketing
Phone: 800-223-9044 ext. 713
Email: ron_kaiser@nidek.com

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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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