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Carl Zeiss Meditec Receives FDA Clearance for Cirrus HD-OCT Software Version 4.0.

- New Anterior Segment Imaging, Normative Database and Change Analysis applications allow eye care professionals to identify disease and monitor progression with greater certainty -

DUBLIN, Calif. -- A new suite of optical coherence tomography Optical coherence tomography (OCT) is an interferometric, non-invasive optical tomographic imaging technique offering millimeter penetration (approximately 2-3 mm in tissue) with micrometer-scale axial and lateral resolution.  (OCT OCT ornithine carbamoyltransferase; oxytocin challenge test.

OCT

ornithine carbamoyl transferase, a liver specific enzyme.

OCT Oxytocin stress test, see there
) software applications for the Cirrus[TM] HD-OCT has been cleared by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for commercial distribution. The Cirrus HD-OCT 4.0 with Retinal Nerve Fiber Layer The nerve fiber layer (or layer of nerve fibers or stratum opticum) is formed by the expansion of the fibers of the optic nerve; it is thickest near the porus opticus, gradually diminishing toward the ora serrata.  and Macular macular adjective Related to 1. A macule 2. The macula  Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

"Throughout our 15 year history of OCT innovation, we have seen its utility evolve from imaging of the retina to now offering both posterior and anterior capabilities," said Michael Kaschke, PhD, President and Chief Executive Officer of Carl Zeiss Meditec. "The Cirrus HD-OCT 4.0 incorporates the latest applications to provide eye care professionals with the tools and analyses needed to manage complex eye conditions throughout a patient's lifetime."

New Tools for Glaucoma Management

With the most robust features for RNFL RNFL Retinal Nerve Fiber Layer
RNfL Real Nappies for London (UK) 
 assessment available in an OCT platform, even subtle abnormalities and changes can be identified between patient visits. Cirrus HD-OCT Version 4.0 offers three tools for quantified glaucoma assessment and management:

* RNFL Normative Database helps to identify retinal nerve fiber layer (RNFL) loss.

* Anterior Segment Imaging provides visualization of the angle and measurement of central corneal corneal

pertaining to the cornea. See also keratitis, keratopathy.


corneal anomaly
includes microcornea, coloboma, megalocornea, dermoid, congenital opacity.

corneal black body
see corneal sequestrum (below).
 thickness.

* Guided Progression Analysis[TM] (GPA GPA
abbr.
grade point average

Noun 1. GPA - a measure of a student's academic achievement at a college or university; calculated by dividing the total number of grade points received by the total number attempted
) software supports glaucoma treatment decision-making by identifying statistically significant changes in RNFL thickness.

"Cirrus 4.0 takes OCT imaging to a whole new level," said Ike K. Ahmed, MD, FRCSC FRCSC Fellow of the Royal College of Surgeons of Canada , Assistant Professor at the University of Toronto Research at the University of Toronto has been responsible for the world's first electronic heart pacemaker, artificial larynx, single-lung transplant, nerve transplant, artificial pancreas, chemical laser, G-suit, the first practical electron microscope, the first cloning of T-cells, . "The GPA and anterior segment imaging capabilities give me increased confidence in determining whether or not my glaucoma patients are responding adequately to therapy or if they require further intervention."

Cirrus HD-OCT RNFL measurements have set a new standard in reproducibility. According to a recent study in British Journal of Ophthalmology, reproducibility of Cirrus HD-OCT RNFL thickness measurements is within a standard deviation In statistics, the average amount a number varies from the average number in a series of numbers.

(statistics) standard deviation - (SD) A measure of the range of values in a set of numbers.
 of 1.2 om for glaucomatous patients1.

Advanced Retina Features

New enhancements to help clinicians better manage retinal diseases and monitor patient response to therapy are also included in Cirrus HD-OCT Version 4.0:

* Macular Change Analysis helps physicians evaluate retinal status and response to therapy by mapping changes in macular thickness.

* Fovea Finder automatically identifies the center of the fovea to ensure the accuracy of macular thickness measurements.

* Macular Thickness Normative Data allows physicians to identify retina disease based on comparison to age-matched data.

"The new Fovea Finder is a one-of-a-kind feature that obtains the precise location of each patient's fovea as a baseline for future scans and for visual comparison of images from one appointment to the next," said Iris Wang, MD, former Research Fellow at Baskin Palmer Eye Institute in Miami, FL. "The superb reproducibility of images along with highly sensitive macular change analysis data allows me to make more informed treatment decisions and to more closely evaluate the benefits of therapy."

Cirrus-HD OCT software version 4.0 is DICOM (medical, standard) DICOM - (From Digital Imaging and COmmunications in Medicine) A standard developed by ACR-NEMA (American College of Radiology - National Electrical Manufacturer's Association) for communications between medical imaging devices.  compatible for use with Carl Zeiss Meditec's connectivity solutions, including VISUPAC Star, and EMR (ElectroMagnetic Radiation) The emanation of energy from everything in the universe. Although the EMR from electrical and electronic devices is typically measured for practical, every-day situations, every object, including humans, emanates energy.  platforms.

"Carl Zeiss Meditec has played a big part in the evolution of OCT and we will continue to bring enhancements to the market in step with clinical advances to support our physician customers as well as growing patient demographics," Kaschke added.

Brief profile

Carl Zeiss Meditec AG (ISIN Isin (ĭs`ĭn), capital of an ancient Semitic kingdom of N Babylonia. The city became important after the third dynasty of Ur fell to the Elamites and the Amorites (c.2025 B.C.). The phase from c.2025–c.1763 B.C. : DE 0005313704), which is listed on TecDAX of the German stock exchange, is one of the world's leading medical technology companies.

The Company supplies innovative technologies and application-oriented solutions which enable doctors to improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat ophthalmic diseases. In the field of Neuro/ENT surgery the Company provides innovative visualization solutions. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising future technologies such as intraoperative radiotherapy.

The Company's around 2,100 employees generated revenue of about EUR EUR

In currencies, this is the abbreviation for the Euro.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 600 million in fiscal year 2007/08 (ended Sept. 30). The headquarters of Carl Zeiss Meditec are located in Jena, Germany. In addition to other subsidiaries in Germany, the Company is represented by over 50 percent of its employees at sites in the USA, Japan, Spain and France.

Thirty-five percent of Carl Zeiss Meditec's shares are in free float. The remaining 65 percent are held by Carl Zeiss AG, one of the world's leading groups engaged in the optical and opto-electronics industry. The five independently run business segments of Carl Zeiss AG operate in the future-oriented markets "Medical and Research Solutions", "Industrial Solutions" and "Lifestyle Products". Carl Zeiss AG is headquartered in Oberkochen, Germany. During fiscal year 2007/08 (ended Sept. 30) the company generated revenues of about EUR 2.7 billion. Carl Zeiss has around 13,000 employees in more than 30 countries, including more than 8,000 in Germany.

For further information please visit our website at: www.meditec.zeiss.com

1 Vizzeri G, Weinreb RN, Gonzalez-Garcia A, Bowd C, Medeiros FA, Sample PA, Zangwill LM. Agreement between Spectral-Domain and Time-Domain OCT for measuring RNFL thickness. British Journal of Ophthalmology. 2009 Mar 19.
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