MARLBOROUGH, Mass.--()--Optos plc (LSE: OPTS), a world leader in retinal imaging, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Microperimetry as part of the OptosOCT SLO. Microperimetry assesses retinal sensitivity providing a precise correlation between structural pathology and corresponding visual functional defects. This data provides more clinical information to support the evaluation of patients’ vision.
The OptosOCT SLO is the only device on the market that can conduct structural OCT and functional Microperimetry testing. This combination makes it easier for eye care professionals to effectively assess treatment results. The Microperimetry test runs in conjunction with a high speed confocal (SLO) and provides real-time tracking of the retinal vessels, resulting in faster perimetry test times and more accurate change over time assessments, compared with standard perimetry.
With today’s new treatments for retinal disease, eye care professionals require additional tools to effectively monitor the results of treatments. Microperimetry provides the eye care professional with the ability to test and quantifiably monitor changes of the patient’s retinal function in a selected location on the retina over time.
Optos’ CEO, Roy Davis commented, “We continue to strive to provide innovative technology to the market. With this 510(k) clearance for microperimetry, we once again offer a unique tool that allows eyecare professionals to see more, diagnose more and treat more diseases earlier. Further it supports our plans for a combined optomap and OCT in the future. This device represents the ‘dream team’ from a diagnostic perspective.”
About Optos plc
Optos plc has the vision to be The Retina Company. We aim to be recognized as a leading provider of devices and solutions to eyecare professionals for improved patient care. Optos' core devices produce ultra widefield, high resolution digital images (optomaps®) of approximately 82% of the retina, something no other device is capable of doing in any one image.
Through acquisition Optos added optical coherence tomography ("OCT") with microperimetry to our product line along with diagnostic devices and optical ultrasound scanners, used in the diagnosis and management of eye disease and conditions. The OCT/SLO delivers an image that shows a three dimensional, cross-sectional view of the retina in any particular area, typically in the central pole area of the retina around the optic nerve and macula and is used to detect the presence of and understand the severity of disease, determine treatment approaches and monitor post-treatment effect.
Further to ultra-widefield retinal imaging and OCT products, Optos has an expanded range of imaging devices that support different customer segments and patient needs. The range includes visual acuity, perimetry and treatment laser products.
For more information please visit our website www.optos.com.
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates and projections about its industry, its beliefs and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the Company's control, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
Note to Editors: Images available upon request