Current Press Releases and News
objectiveFIELD™, a Ground Breaking, FDA 510(k) Cleared Objective Perimeter Announced by Konan Medical USA
objectiveFIELD, a visual-field testing device that requires no manual patient push-button responses, has been acquired by KonanMedical USA.
Irvine, CA – October 10, 2018
objectiveFIELD is a novel, FDA-cleared device designed to assess the human visual field in a completely objective and non-contact manner. Unlike the conventional method currently in use in most eye doctors’ offices, there is no need for any manual input from the patient. Using a patented multi-focal pupil objective perimetry method (mfPOP), objectiveFIELD tests both eyes simultaneously in only a few minutes.
objectiveFIELD has been clinically researched in Australia over more than a 12-year period with more than 16,000 examinations…
Nexy Robotic Retinal Imaging System Cleared by the FDA for the US Market
Nexy™, a next generation robotic retinal imaging system, has been cleared by the FDA for sale into the US market offering hands-off operation as well as features to integrate telemedicine and AI applications.
Irvine, CA – June 12, 2018
Available now, Nexy is a new FDA 510(k) clerked, CE-marked retinal camera that features fully robotic operation resulting in remarkably clear and detailed retinal images. Designed for use in ophthalmology, optometry, hospitals, clinics and many other point-of-service locations, as well as health screening environments, Nexy leverages innovative technology to drive a value-priced retinal examination in which a minimally trained operator can easily acquire images virtually hands-off.
Nexy is being used in Europe for diabetic eye-screening and other health-care initiatives to provide access to care in minimally served locales by way of an optional service in which an expert can “read” securely distributed images instantly with an opinion rendered electronically. This telemedicine feature may also be used to integrate with Artificial Intelligence, or “AI” processing engines to extract additional information from retinal imaging.
Konan Medical’s EvokeDx®, the Next Generation VEP + ERG Vision Diagnostics Platform, Achieves the CE Mark Including Glaucoma Diagnostic Indication
Robust, User-Friendly and Affordable In-office Visual Pathway Diagnostics Technology Featuring icVEP™ Provides Important Information About the Functional Integrity of the Visual System.
Irvine, CA – July 17, 2017
Konan Medical, a global leader in innovative diagnostic devices for the ophthalmic industry, today announced that it has attained the CE mark for its newest device, EvokeDx. The CE mark is required in Europe by 30 countries in order to market medical devices and is an assurance that the product complies with relevant European health, safety and environment protections. EvokeDx is now approved in Europe for objective assessment of central vision function including the diagnosis of glaucoma.
Konan Medical Releases ColorDx® Pro Color Vision Diagnostics for iPad®
Irvine, CA – January 21, 2015
Konan Medical, a global leader in innovative diagnostic and examination devices for the ophthalmic industry today announced that it has released ColorDx Pro, a pseudo-isochromatic color vision test app for iPad.
Konan Medical Introduces EvokeDx™, the Next Generation VEP plus ERG Vision Diagnostics Platform
Irvine, CA – November 13, 2014
Konan Medical, a global leader in innovative diagnostic devices for the ophthalmic industry today announced that it has launched its newest device, EvokeDx – the next-generation visual pathway diagnostics platform to assess visual evoked potentials (VEP) and electroretinograms (ERG).
FLEX Visual Acuity Released on Chart2020® DUO iPad App by Konan Medical
Konan’s Chart2020®, an international leader in visual acuity and ocular performance testing software adds the professional-grade FLEX™ visual acuity app now available on the Chart2020 DUO app at the Apple iTunes store and showcased at the ASCRS meeting in Boston.
A feature-rich FLEX visual acuity app for Ophthalmology, Optometry, clinical trials and other medical uses has just been released on Apple iTunes for Retina display iPad devices as an add-in to Konan Medical’s Chart2020 Duo app. The FLEX visual acuity test allows clinicians to dynamically and instantly adjust visual acuity test parameters to test from 33 cm (14 inches) to 6 meters (20 feet). The test includes industry standard, Sloan specification literate, illiterate, and pediatric optotypes for western and 6 global languages. FLEX is gesture- driven to simply and intuitively display acuity lines, single letters, and full charts including smart randomization and reverse contrast on retina display iPad devices.
Next Generation Visual Evoked Potential “icVEP” Technology Rights Acquired by Konan Medical
Konan Medical USA announces acquisition of rights to market Neucodia’s enhanced visual electrophysiological technology, EvokeDx™ for assessment of visual pathway disorders internationally. Featuring the patented icVEP test strategy, EvokeDx sets a new standard for clinical excellence and ease of use, at a price point that is affordable for all eye care practices.
The next generation visual evoked potential device, EvokeDx™ will be brought to market by Konan Medical USA. Visual evoked potentials have been used to assess various problems in the vision pathway (retina to brain), but have had limited appeal to Ophthalmology and Optometry practices due to difficulties in interpretation and administration. As a fully integrated system, EvokeDx sets a new standard for the eye care practice: faster, easier to use and interpret, smaller, and less expensive.
EvokeDx, a FDA 510(k) cleared system, features a patented visual stimulus “icVEP” and novel analysis methods Tcirc2 and Fstat to elicit enhanced results with simplified interpretation. Results of a recent US multi-center clinical trial were presented at ARVO in which the EvokeDx icVEP technology was used to assess glaucoma damage to the visual pathway. The study data showed that the icVEP strategy provided strong differentiation between normal eyes and glaucoma affected eyes with an overall accuracy estimate (glaucoma cases vs. controls) of A′ = 89.2%. An additional, independent study last year in Beijing, China on the technology both confirmed this accuracy of classification (92%) and provided data which led to issuance of the first VEP glaucoma diagnostic indication in China.
Konan Medical Releases Medical Media Features as Enhancement to Chart2020® DUO App For iPad
Konan’s Chart2020®, a global leader in visual acuity and ocular performance testing software, has just been enhanced with specialized eye medical illustrations and videos to enable improved physician – patient communication. The Media Library feature is now available on the Chart2020 DUO app at the Apple iTunes® store, and will be showcased at the Vision Expo East conference in New York.
A new Media Library has been released on Apple’s Retina iPad® as an enhancement of Konan’s Chart2020 DUO application. As with the Blind Spot Amsler™ feature, the Media Library is available for a limited time at an introductory price from the iTunes Store®. The first release of the Media Library includes patient-friendly illustrations and videos on a wide range of eye disease and surgery topics such as macular degeneration, refractive surgery, cataract surgery, color vision / color blindness, diabetic retinopathy, endothelial dystrophies and more. The Media Library was developed to be extensible with future versions allowing third party images and other educational features.
Konan Medical Announces New Edition of ColorDx® Color Vision Tests for Children and Adults
The Waggoner PIP 24™ and Color Vision Testing Made Easy™, industry standard tests for color vision testing, are now available as Konan’s new ColorDx® series in a new easy to administer print format and will be showcased at the Vision Expo East conference in New York.
New ColorDx® tests in print are now available with value added features. Using the latest colorimetry-corrected printing methods, the ColorDx Standard 24, is a 6-confusion pseudoisochromatic color test for color vision deficiencies (the “PIP 24”). The Standard 24 features the military validated adult / literate test, new administration features, enhanced reporting, a market-proven illiterate / pediatric test section.
Simultaneously, a new edition of Color Vision Testing Made Easy™, has been released as ColorDx Pediatric 15. This test is designed for young children, very young children and mentally challenged individuals. The test is widely considered to be the gold standard for pediatric color vision assessment and as such has been used exclusively by the Special Olympics for testing Special Olympian’s color vision skills.
Konan Medical Announces Introduction of the Amsler Grid App for iPad®
Konan’s Amsler test is now available on Apple iTunes® store, and will be showcased at the Vision Expo East conference in New York and SECO in Atlanta.
IRVINE, CA – MARCH 13, 2014
The Amsler test for iPad® is a newly released add-in feature of Konan’s Chart2020 DUO, available for a limited time at an introductory price from the iTunes Store®. The Amsler test provides a basis for easily controlling test distances, important for repeated tests over time. The Amsler test is featured by the Macular Degeneration Foundation’s web site. Macular Degeneration is the leading cause of vision loss in Americans over age 60.
Aerospace Medical Association Bestows First Tredici Award to Ophthalmologist Matthew Rings for Color Vision Diagnostics Research
Captain Mathew Rings, MC, USN has been named as the first recipient of the Aerospace Medical Association’s newest award for excellence, the Thomas J. and Margaret D. Tredici Award for his research on Konan ColorDx color vision testing and qualifications for US Navy and Marine Corps aviation.
IRVINE, CA – AUGUST 13, 2013
The Aerospace Medical Association (“AsMA”) has granted the first Thomas J. & Margaraet D. Tredici Award for the most significant contribution to aerospace ophthalmology and vision science to Matthew Rings, MD. Dr. Rings was recognized for his leadership in the study of operational color vision testing and qualifications of U.S. Navy and Marine Corps aviation. As the lead researcher, the team compared and validated various color vision testing programs for both screening and comprehensive assessment of aviation applicants and designated personnel.
Konan Medical Launches CHART2020™, Cutting Edge Visual Acuity Software
Irvine, CA – OCTOBER 04, 2013
Konan Medical USA, Inc. today announced it has completed a world-wide exclusive agreement with Chart2020, a leading provider of visual acuity and ocular performance testing software. Konan will develop, market and distribute Chart2020 globally.
Chart2020 v5 is an advanced vision testing software platform with a completely redesigned user experience that can be controlled with the Chart2020 Duo APP for iPad® with Retina® display. The iPad can also be used to administer a number of guided, self-scoring tests including ColorDx™, Konan’s new color vision testing software.
Konan Receives the Europe's CE Mark for RAPDx® Pupil Diagnostic Device
Konan Medical USA’s new RAPDx high definition pupillograph has received Europe’s CE Mark and sales will begin in Europe and other countries recognizing the CE Mark beginning at the largest European Ophthalmic congress, the ESCRS, in Milan, Italy.
Irvine, CA – SEPTEMBER 04, 2012
Konan Medical USA, Inc. has announced that its RAPDx® pupillograph for screening of defects in pupil function has received the European CE Mark. The CE Mark identifies that the RAPDx device has met the EU’s health and safety standards and the company will begin shipping product to Europe and other countries recognizing the CE Mark in conjunction with the September 2012 ESCRS meeting in Milan, Italy.
Konan Medical USA Achieves ISO 13485 Certification
International certification milestone reached in preparation for entry of RAPDx product into EU, Canada and other countries.
Irvine, CA – December 16, 2011
Konan Medical USA, the US market leader in specular microscopy, reported that its Quality Management System has been certified to the requirements of both ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS) by Intertek, a notified body based in the United Kingdom.
An internationally recognized standard, ISO 13485 specifies requirements for a quality management system governing design, manufacture, and support of medical devices, and is a cornerstone for medical device companies to gain entry into a significant number of the world’s developed markets. Certification of Konan’s quality system is a critical step towards CE Marking its newly announced RAPDx pupillography product in European, Canadian and other jurisdictions that recognize the CE Mark.