Navigation Links
Optovue Receives FDA Clearance on OCT Normative Database
Date:9/17/2010

FREMONT, Calif., Sept. 17 /PRNewswire/ -- Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the U.S., announced that it has received 510(k) clearance on its Normative Database ("NDB") for the RTVue OCT device.

"This affirms that our protocols and management of this large international, multi-site normative population are at the level that FDA regulatory guidelines require," stated Mike Sinai, PhD, Sr. Director of Clinical Research for Optovue. "Most importantly, this demonstrates the safety and efficacy of our NDB based on FDA current standard for its intended uses. Furthermore, this is the only normative database taking into account patient age, signal strength of the scan, and even optic disk size in certain scans. These factors along with the large normal sampling, offers clinicians a high degree of confidence in our NDB as a reference tool in assessing retina nerve fiber thickness."

The NDB for the RTVue system comprises over 600 eyes for the pending U.S. release, and is the largest FDA cleared NDB for an OCT device. Optovue plans on releasing the RTVue application update containing the newly cleared NDB for customers in the next several weeks.

About RTVue and iVue

RTVue was the first FDA cleared Fourier domain (also known as spectral domain) OCT launched in the United States, and also the first OCT cleared by the U.S. Food and Drug Administration for both corneal and retinal imaging. The iVue is the compact fourier-domain version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician.

About Optovue (www.optovue.com)

Optovue Inc. is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, CA, with operations in Carlsbad, CA and European operations in Heidelberg, Germany. Contact:Paul KealeyVice President Marketingpaul_kealey@optovue.com510-623-8868 ext. 105John TalaricoVice President Regulatoryjohn_talarico@optovue.com510-623-8868
'/>"/>

SOURCE Optovue Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Boston Scientific Receives Exclusive Expanded Indication for Its CRT-Ds
2. New England Biolabs Receives Award to Develop Novel Enzymatic Reagents for Epigenetic Studies
3. Amedica® Receives Patents for Innovative Motion-Preserving Total Disc Implant Featuring Silicon Nitride
4. Masimo Noninvasive and Continuous Hemoglobin Receives Market Clearance in Japan
5. Assured Pharmacy Receives $500,000 in Debt Financing
6. Arcion Therapeutics Receives FDA Fast Track Designation for ARC-4558 for the Treatment of Pain Associated with Painful Diabetic Neuropathy
7. QuantaLife, a New Life Science Tool Company, Receives NIH Grant
8. Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing
9. National University Hospital Singapore Receives DSRB Approval to Use TIGR® Matrix Surgical Mesh in a New Randomized Controlled TRAM Flap Study
10. CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
11. Say Goodbye to Unwanted Love Handles: CoolSculpting by ZELTIQ™ Receives FDA Clearance for Patented, Non-Invasive Cooling Treatment for Fat Reduction
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... HILLS, Calif. , June 23, 2016 Any ... the many challenges of the current process. Many of them ... because of the technical difficulties and high laboratory costs involved. ... have to offer it at such a high cost that ... afford it. Dr. Parsa Zadeh , founder ...
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... -- , , , WHEN: , ... , , , LOCATION: , , , Online, with free ... EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice President ... Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... is witnessing an exceptional era. Several new demand spaces, such as ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
Breaking Medicine News(10 mins):