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Archive for the ‘press’ Category

NIDEK Receives FDA Marketing Clearance For NIDEK MC-300 – Multicolor Laser Photocoagulator

Monday, August 4th, 2008

Fremont, California, April 15, 2005

MC-300 NIDEK MC-300 NIDEK Inc. a US leader in advanced ophthalmic laser technologies announced today that it received FDA marketing clearance for commercial release of its new MC-300 Multicolor Laser Photocoagulator System. The new laser will continue to establish NIDEK as a comprehensive laser provider for the fast growing retinal laser market. The MC-300 laser system has been commercially available in international markets and has received outstanding reviews and clinical results from retinal specialists in Asia and Europe. The NIDEK MC-300 is an advanced multi-color (red, yellow and green) diode-pumped solid-state (DPSS) laser system. The new laser delivers three unique laser wavelengths – 659, 561 and 532 nm – ideal for retinal applications, disease treatments and management. The new retinal photocoagulator features advanced software technologies for accurate and precise energy delivery to the retina. In addition, with advanced SOLIC Technology – the new system features digitally controlled instant duty cycles, permitting the laser to be used at rapid speeds and high powers for extended periods of time without failure and energy decay. The MC-300 laser can be mounted for slit-lamp delivery and requires a standard electric outlet, offering retinal surgeons with advanced delivery capabilities and versatility in either an operating room or in-office use. NIDEK will launch the new MC-300 laser at the American Society For Cataract & Refractive Surgery – ASCRS Annual Meeting in Washington, DC, April 16th – 19th, 2005. “The NIDEK MC-300 is an outstanding laser for retinal applications, delivering a suite of advanced technologies to the retinal specialist. With the introduction of the MC-300, NIDEK continues its long-standing commitment to delivering advanced solutions for all specialties of ophthalmology, including retinal applications. Together with the MC-300 and other diagnostics and laser solutions, NIDEK continues to forge ahead and build a solid franchise for delivering products and solutions that deliver on superior technology, product reliability, performance and outstanding clinical results, with a focus in the areas of cornea, cataract, glaucoma and retina.” commented Mr. Hideo Ozawa, President & Founder of NIDEK, at a recent product release event. Mr. Ted Shimomura, Vice-President & General Manager of NIDEK Inc. commented; “The NIDEK MC-300 is an innovative break-through in ophthalmic multi-wavelength laser technology, delivering a solution that retinal specialists have been asking for in the US market for the last few years. Today there is only one other company that delivers a solution that is really not the ideal platform for retinal laser applications; now NIDEK is introducing a solution that is better in clinical results, more reliable, user-friendly and offers newer technology for the retinal specialist. In the months ahead, we look forward to having the MC-300 becoming the de-facto standard for retinal lasers. With new lasers and diagnostic solutions being introduced at this year’s ASCRS Meeting, NIDEK continues to forge ahead and make stronger in-roads into the US ophthalmic laser and diagnostic instrumentation market.”

NIDEK YC-1800 Ophthalmic YAG Laser System Given Commercial Release In US

Monday, August 4th, 2008

Fremont, California, April 15, 2005

NIDEK Inc. a US leader in advanced ophthalmic laser equipment announced today that it has made it’s new and state-of-the-art YC-1800 Ophthalmic YAG Laser System available for sale to the US market. The new laser platform will further advance and fortify NIDEK’s strong leadership position in the ophthalmic laser industry in the US and on a global basis. The NIDEK YC-1800 is an advanced ophthalmic laser platform, combining innovative laser delivery and output technologies, improved operability, fast operation, super adjustable Nd:YAG offset and compact design with versatility for combination laser systems. NIDEK will release and launch the new YC-1800 laser at the American Society For Cataract & Refractive Surgery ASCRS Annual Meeting in Washington, DC, April 16th – 19th, 2005. “The NIDEK YC-1800 is truly an innovative YAG laser system, unlike any currently available on the market on a global basis. The laser combines advanced application features, laser settings parameters and unique design to deliver to the ophthalmic surgeon a solution unlike any other. NIDEK continues to deliver solutions that offer performance, advanced features, reliability and state-of-the-art technology to the ophthalmic surgeon. We continue our long-standing partnership with the ophthalmic surgeon; dedicated to delivering solutions that will advance patient care and improve treatment.” commented Mr. Hideo Ozawa, President & Founder of NIDEK, at a recent product release event. Mr. Ted Shimomura, Vice-President & General Manager of NIDEK Inc. commented; “The NIDEK YC-1800 is an innovative break-through in ophthalmic YAG laser technology, delivering a suite of features that will provide outstanding reliability and service to the user and enable them to provide excellent patient care. With the YC-1800 Laser, NIDEK further advances and fortifies its strong leadership position in the US in the ophthalmic laser market. With the introduction of this laser platform, we bring to the US market our 5th generation Nd:YAG Laser solution – over 20 years of continued innovation and excellence. NIDEK is dedicated to delivering outstanding product reliability with a keen eye on advanced technologies for the ophthalmic industry. We look forward to the YC-1800 becoming the standard of care with every ophthalmic surgeon. The 2005 ASCRS Meeting is an important one for us, as we are also in the process of introducing other ophthalmic laser solutions and furthering our strong leadership position.”

 

NIDEK – Two Sister Companies Merge to Combine Efforts in U.S. Ophthalmic Industry

Monday, August 4th, 2008

Fremont, California, October 21, 2005

NIDEK – Two Sister Companies Merge to Combine Efforts in U.S. Ophthalmic Industry Fremont, California, October 13, 2005 NIDEK Co., Ltd. announced today that its two wholly owned subsidiary companies – NIDEK Technologies America (NTA) and NIDEK Inc. would merge and consolidate business activities in the US market effective April 1st, 2006. NTA with a focus in commercializing advanced ophthalmic diagnostic instrumentation for corneal and retinal applications, will merge with NIDEK’s U.S. sales and marketing organization – NIDEK Inc. This consolidation and merger is being undertaken to further harmonize and harness commercial synergies and solidify NIDEK’s strong and growing business in the U.S. vision care and ophthalmic industry. The company sees this strategic move as a way to further its product marketing and distribution goals and objectives in the United States. “This is an exciting time for NIDEK’s business operations in the US, as we continue our strong focus on harnessing business and product distribution synergies in the US. ” stated Mr. Hideo Ozawa, President & Founder of NIDEK Co., Ltd. “With this merger / operational consolidation we want to focus our efforts on the strong synergies that both NTA and NIDEK Inc. bring to the marketplace. Bringing the two groups together will allow NIDEK to offer one source for its advanced diagnostics and surgical ophthalmic instrumentation to the visioncare professional in the U.S. Additionally, through this consolidation we aim to streamline business operations – sales, marketing, accounting, customer and product service – enabling NIDEK to focus and achieve its short and long-term goals and objectives. Under one business unit, NIDEK Inc. will continue to provide excellent customer service and deliver to the market innovative, technologically advanced products and services, as it has done for close to 25 years,” added Mr. Hideo Ozawa. “Harnessing synergy is our objective here – by bringing together the two commercial business operations, NIDEK as company will be able to focus on leveraging core competencies of each group and continue to develop and market new and innovative advanced ophthalmic diagnostic instrumentation to the US,” stated Phillip Buscemi, OD, Vice President and General Manager of NIDEK Technologies America. “To our existing and new customers, the business change will be seamless and transparent. We will transfer product marketing, sales, service, and customer support to our sister operation at NIDEK Inc. in Fremont, CA. The goal here is to harness commercial, distribution and operational synergies between the two groups and continue our long standing partnership with our users in the United States”, added Mr. Buscemi. “As we see our business and company dealings in the U.S. grow, its important that we bring together akin and analogous business operations together and by doing this, we continue to harness synergies and organizational core competencies to continue to deliver products and technologies to our customers in the United States and around the world. At NIDEK we want to focus on key strategic areas – diagnostic technologies being one of those. By bring NTA and NIDEK Inc. together, we will continue to drive the advancement of technology and enable NIDEK to continue its strong business history in the U.S. and the global ophthalmic and vision care markets. Our end goal here is to continue to deliver products that offer Visionary Performance to our users around the world”, added Mr. Hideo Ozawa. With worldwide operations headquartered in Gamagori, Japan, NIDEK develops, manufactures and sells laser systems and diagnostic equipment for ophthalmology, optometry, general surgery, gynecology and cosmetic dermatological surgery. NIDEK’s ophthalmic and optometric products are specifically designed for diagnosing and treating retinal diseases, glaucoma, refractive therapies, retinopathy of prematurity, and pre- and post-operative cataract surgery therapy. NIDEK’s surgical products are designed to treat patient in the growing applications of cosmetic laser surgery and laser skin resurfacing. NIDEK distributes its products through a network of distribution partners and a direct sales force.

For further information contact:

Mr. Kuntal Joshi
Title: Director of Global Marketing, NIDEK Co. Ltd.
Phone: 510.226.5700 – ext 803
Fax: 510.226.5750
Email: kuntal_joshi@nidek.com

Mr. David MacLellan
Title: Director of Marketing / Sales, NIDEK Technologies America
Phone: 336.851.0225
Fax: 336.851.0917
Email: dmaclellan@nidektech.com

NIDEK, Inc. Announces a Significant Increase in Ophthalmic Diagnostic Product Offerings through the Merger with NIDEK Technologies America

Monday, August 4th, 2008

Fremont, California , April 3, 2006

NIDEK – Effective April 1st, 2006, NIDEK Technologies America (NTA) of Greensboro, NC, has merged with NIDEK Inc. of Fremont, CA. As a global leader in eye care products for ophthalmology and optometry, NIDEK is consolidating its clinical, development, distribution, marketing and sales efforts in the United States to NIDEK’s location in Fremont, CA. This allows NIDEK to expands both it’s customer base, and increase product offerings to new and existing customers. “This is an exciting time for NIDEK’s business operations in the US, as we continue our strong focus on harnessing business and product distribution synergies in the US,” states Mr. Hideo Ozawa, President & Founder of NIDEK Co., Ltd. “With this merger we want to focus our efforts on the strong synergies that both NTA and NIDEK Inc. bring to the marketplace. Bringing the two groups together will allow NIDEK to offer one source for its advanced diagnostics and surgical ophthalmic instrumentation to the vision care professional in the US.” The focus of NTA is to develop advanced ophthalmic diagnostic instruments for corneal and retinal applications. One of the new releases is the Magellan Mapper, the most accurate system that maps any corneal aberration, providing more information to explain the patient’s vision. Currently, it has the highest resolution of any topography system on the market, and is a leading seller.

NIDEK Inc., a larger corporation, is continually growing to develop an array of laser and optical scanning products that lead the way for improved diagnosis and treatments.

CONTACTS:
Mr. Mitsutoshi Amano, Manager of Corporate Planning NIDEK Co., Ltd.
Phone: 81-533-67-6753
Fax: 81-533-67-6610
Email:mitsutoshi_amano@nidek.co.jp
Website: www.nidek.com

Mr. Frank Wood, Marketing Manager NIDEK, Inc.
Phone: 800-223-9044
Fax: 510-226-5750
Email: frank_wood@nidek.com
Website: www.usa.nidek.com

IN-VIVO DETECTION OF FUNGAL KERATITIS

Monday, August 4th, 2008

Fremont, California, May 19, 2006

NIDEK Inc. announces plans to help doctors cope with the nationwide Fusarium fungal keratitis outbreak. As of late April, a total of 73 cases in the United States had been confirmed with fungal keratitis, with another 113 still under investigation, according to FDA. The Centers for Disease Control and Prevention now list 29 states or territories with a confirmed case or one under investigation. The NIDEK Confoscan4 scanning slit confocal microscope is able to image these infections in-vivo. This allows for a diagnosis in minutes, while traditional techniques involving cultures or biopsies can take a week or longer. “The Confoscan is invaluable to us in early diagnosis of fungal keratitis. Identifying the type of infection and being able to initiate the appropriate treatment as soon as possible is vital to keeping these infections from becoming critical,” says Dr. Eduardo C. Alfonso of the Bascom Palmer Eye Institute of the University of Miami, Miami, Florida. NIDEK has set up a referral website (Confocal Sites) to help doctor’s locate Confoscan microscopes in their area. NIDEK will also be working closely with the doctors at Bascom Palmer to establish a reading center to assist physicians who do not routinely see patients with fungal keratitis and perform imaging with in-vivo corneal confocal microscopy.

NIDEK is a global leader in eye care products for ophthalmology and optometry. With diversified clinical research and continual development, an array of laser and optical scanning products are offered that lead the way for improved diagnosis and treatments.

 

NIDEK Gains FDA Approval for Hyperopia and Hyperopic Astigmatism Module on EC-5000 Excimer Laser

Monday, August 4th, 2008

Fremont, California, October 18, 2006

NIDEK, Inc. a global leader in laser and diagnostic instrumentation for the optical and eye care industry, announced today that the U. S. Food & Drug Administration (FDA) has approved its EC-5000 Excimer Laser for the treatment of hyperopia and hyperopic astigmatism for use in LASIK. With this approval, ophthalmic surgeons are able to treat hyperopia and hyperopic astigmatism (+0.50D to +5.00D sphere and up to 2.00D cylinder) in addition to the current approved range for myopia and myopic astigmatism. Hyperopia or farsightedness may be surgically treated by laser vision correction or LASIK. Mr. Motoki Ozawa, Vice President, NIDEK Co., Ltd stated, “This is a historic event for NIDEK and we are especially pleased to have this long-awaited approval. The excellent and outstanding results from 291 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 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 in vision care”, Mr. Ozawa said. The following chart demonstrates six month follow up results of the safety and effectiveness of the EC-5000 Hyperopia clinical results:

Six Month Follow Up Results (291 eyes)
69% within ± 0.5 D
93% within ± 1.0 D
60% 20/20 or better (UCVA)
86% 20/25 or better (UCVA)
99% 20/40 or better (UCVA)

 

NIDEK Receives FDA clearance for Excimer Laser System Model CXIII

Monday, August 4th, 2008

Fremont, California. November 22, 2006

NIDEK Inc. a global leader in laser and diagnostic instrumentation for the optical and eye care industry, announced that it has received marketing clearance from the Food and Drug Administration (FDA), for its advanced refractive laser surgery system the CXIII EC-5000 Excimer Laser System. With this clearance, NIDEK continues to deliver the latest vision correction solutions to ophthalmologists around the world.

“This clearance is a great step forward and NIDEK is excited to be in a position to help doctors ensure good quality of life for their patients.” said Motoki Ozawa, CEO and President of NIDEK Incorporated.

CXIII, which is already CE-marked approved, offers the latest, innovative solutions for Myopia, Myopic Astigmatism, Hyperopia and Hyperopic Astigmatism in the US. CXIII includes a built-in 200 Hz eye tracker and also available is a built-in LCD “heads-up” monitor that displays operation mode, parameter settings, microns of ablation and image of the patient’s eye for tracking as optional.

NIDEK Announces Auto-Focus, Auto-Alignment Fundus Camera

Monday, August 4th, 2008

Fremont, California. April 18, 2007

NIDEK Inc. announces the release of their new auto-focus, auto-alignment non-mydriatic fundus camera. The AFC-210 Pro Photographer takes true 45° images, without any cropping, and very high resolution of 12.8 mega pixel images. This camera delivers superior diagnostic detail, meeting government standards and reading center criteria for diabetic retinopathy screening.

The highly automated design is so simple to use that, someone with limited experience, can take professional quality retina images after just a few minutes of guidance. The AFC-210 Pro Photographer is ideal for busy optometry or ophthalmology offices, where staff turn-over can be a reoccurring challenge. With this camera, anyone can easily take excellent retina images, even externals. .

These high resolution images are optimal for early diagnostic diabetic screening. Diabetes is one of the world’s fastest growing pandemics, increasingly effecting the population. Early diabetic screening can vastly improve diabetic care, and reduce needless vision loss. Development and implementation of standardized diabetic screening will not only give early detection, and but also improve the ability to treat diabetes earlier.

NIDEK is a global leader in eye care products for ophthalmology and optometry. With diversified clinical research and continual development, an array of optical laser and camera products are offered that lead the way for improved diagnosis and treatments.

For more information, please contact:

Frank Wood
Marketing Manager
NIDEK Inc.
Phone: 800-223-9044
Fax: 510-226-5750
email: frank_wood@nidek.com

NIDEK Gains FDA Clearance for ORION, a New Auto-Retinal Imaging Device

Monday, August 4th, 2008

Fremont, California – Apr 29, 2007 (PRN):

NIDEK, Inc. a global leader in laser and diagnostic instrumentation for the optical and eye care industry, announced today that the U. S. Food & Drug Administration (FDA) has approved the first product of the AutoEase™ line called ORION, an Auto-Retinal Imaging device for use in screening patients for retinal diseases such as diabetic retinopathy and AMD.

With this approval, ophthalmologists, optometrists and family physicians are able to identify retinal diseases in patients and refer them to a retinal specialist for further diagnosis and treatment. .

With its ease of use as an Auto-Retinal Imaging device, ORION enables patients to screen their retina without the assistance of a technician. The primary method of operation behind ORION includes a voice synthesizer. The voice prompts the patient through the screening process and captures a 7 micron, high resolution image of the patient’s retina, which can be electronically sent to a retinal specialist for further diagnosis. In addition, ORION can screen both retinas of a patient in less than 2 minutes. .

Mr. Motoki Ozawa, Vice President, NIDEK Co., Ltd stated, “ORION is a perfect addition to NIDEK’s strong, world-class product portfolio in unsurpassed diagnostic and surgical instrumentation, optical finishing and dispensing products in vision care”.

About NIDEK NIDEK is a global leader in diagnostic and surgical eye care products for ophthalmology and optometry focused on developing and delivering innovative technologies that enhance the quality of human life. With diversified clinical research and continual innovative development, an array of laser and optical scanning products offered that lead the way for improved diagnosis and treatments. The relentless commitment to customer satisfaction means NIDEK will diligently strive to continually exceed expectations. .

The NIDEK Inc. logo is available at .

http://www.primezone.com/newsroom/prs/?pkgid=1006.

ANNOUNCEMENT OF NEW PRESIDENT AND CEO OF NIDEK CO., LTD.

Monday, August 4th, 2008

June 24, 2008 NIDEK CO., LTD.

Gamagori, JAPAN, — NIDEK Co., Ltd. announced that Mr. Hideo Ozawa was appointed Chairman of the Board, and Mr. Motoki Ozawa was promoted to President and CEO. This decision was approved at the Board Meeting, after the Annual Shareholders Meeting on June 24, 2008. Under this new management, NIDEK will continue to target further growth in ophthalmic and aesthetic markets as well as optical systems and the coating business.

Mr. Motoki Ozawa, the new President, initially assumed his post as NIDEK, Co. Ltd. as Vice President in 2005, and has since become President and CEO. Mr. Hideo Ozawa, Chairman, is the founder of NIDEK and has devoted himself to corporate management and to the innovation of the ophthalmic industry since the NIDEK foundation began 37 years ago.

NIDEK started from the conviction of former President Mr. Hideo Ozawa, that he would make things “invisible to visible”. We sincerely appreciate your devoted support that made our growth to date possible. We continue to embrace Mr. Ozawa’s conviction. In my opinion, our corporate social responsibility role will be enhanced in this advanced information age and with our aging societies. We plan to make further efforts to grow through clinical contributions to the healthcare industry that will become beneficial to our societies. Your continued support is greatly appreciated.

About NIDEK CO., LTD.

NIDEK has been doing worldwide business in the medical, optical and coating fields based on leading-edge optoelectronic technology. It develops, manufactures and sells products in the above fields, provide after-sales service and export the products to about 100 countries. It will continue to support people all over the world for their healthy lives as a leading company in the ophthalmic and optical instrument industries. For further information, please visit our web site.

http://www.usa.nidek.com
http://www.nidek.com

 

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    NIDEK Inc.
    47651 Westinghouse Drive
    Fremont, CA 94539
    Telephone: 1-510-226-5700
    Sales and Support: 1-800-223-9044 (USA Only)
    Fax: 1-510-226-5750