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 profess
'/>"/>

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

Page: 1 2

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:1/15/2014)... 15, 2014  Humberto C. Antunes,  Galderma  worldwide CEO, will ... Journal of Drugs in Dermatology (JDD) at ... The event is January 17-20, 2014, at the Omni Orlando Resort ... The ODAC is a distinguished event that ...
(Date:1/15/2014)... , Jan. 15, 2014 Tegra Medical is very pleased ... as its new Chief Executive Officer.  Mark was promoted ... he has overseen the company,s four facilities in ... Rica.  Mr. King joined Tegra Medical in 2012 with 20+ ...
(Date:1/15/2014)... Jan. 15, 2014  According to Millennium Research Group ... intelligence, the United States ... markets will expand moderately through 2022, with embolization ... particular, increasing interest in drug-eluting beads (DEBs) and ...
Breaking Medicine Technology:Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4Tegra Medical Appoints New Chief Executive Officer 2Tegra Medical Appoints New Chief Executive Officer 3US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3
(Date:4/18/2014)... news release is available in French . ... could revolutionize surgical practice and regenerative medicine. A team ... et Chimie (CNRS/ESPCI Paris Tech) and Didier Letourneur from ... Paris 13), has just demonstrated that the principle of ... in vivo to repair soft-tissue organs and tissues. This ...
(Date:4/17/2014)... chronic inflammation in non-cancerous prostate tissue may have nearly ... those with no inflammation, according to results of a ... Kimmel Cancer Center. , The link between persistent inflammation ... high-grade prostate cancer those with a Gleason score ... the most aggressive and rapidly growing prostate cancers. , ...
(Date:4/17/2014)... popular vaccine brands for children may not be the ... cost factors when choosing vaccines, driving the market toward ... a new study by University of Illinois researchers. , ... by numerous factors," says Sheldon H. Jacobson, a co-author ... and of mathematics at the U. of I. "In ...
(Date:4/17/2014)... Diego School of Medicine report that older women, plucky ... loss are more likely to be compassionate toward strangers ... in this month,s issue of the International Journal ... associated with better health and well-being as we age, ... the outcomes of individuals whose deficits in compassion put ...
(Date:4/17/2014)... Pediatrician-in-Chief Jon McCullers, MD, was recently invited to ... Nature Reviews Microbiology , one of the ... world-renowned infectious disease specialist, and chair of the ... Health Science Center, analyzed the epidemiology and microbiology ... pandemics, as well as more recent 2009 novel ...
Breaking Medicine News(10 mins):Health News:Innovative strategy to facilitate organ repair 2Health News:Innovative strategy to facilitate organ repair 3Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Study recalculates costs of combination vaccines 2Health News:The ilk of human kindness 2
... Prompts Extension of Promotion -, DENVER, July ... of functional foods, beverages and nutritional,supplements, announced that ... of the $1 million sales goal for the ... opportunity to earn,significant bonuses in July., John ...
... hardest hit states by this legislation, WASHINGTON, July ... significant funding cuts under legislation being,considered in Congress, according ... As Congress considers ways to halt the impending cut ... Medicare Advantage program to,pay for the fix. Legislation currently ...
... July 2 VNUS(R) Medical,Technologies, Inc. (Nasdaq: ... the minimally invasive treatment of venous reflux disease, ... in the United States,District Court, Northern District of ... (Dornier) and NewStar Lasers,Inc. d/b/a CoolTouch, Inc. (CoolTouch)., ...
... ushers in The Art of Condoms (FDA-approved), as the ... latest hi-tech advancement in safe-sex., ... of designer-condoms. Remarkably shaped condoms,including the look-alike Dolphin Condom(TM) and ... designers could only dream,of making before. The Dolphin(TM) has all ...
... for environment, MELROSE PARK, Ill., July 2 ... that it has surpassed the,sale of 1 million green ... "We are seeing more and more people buying ... Jewel-Osco. "This is,likely due to the heightened awareness about ...
... disease can save some vision, experts say , , WEDNESDAY, ... to end in blindness, two new studies suggest. , ... for glaucoma has better outcomes than using glaucoma drainage ... end-stage glaucoma can be successfully treated. Both studies were ...
Cached Medicine News:Health News:XELR8 Holdings Announces Continuation of 'XELR8 To A Million' Promotion 2Health News:Proposed Congressional Legislation Would Cut $784 Million From the Medicare Advantage Program in New York 2Health News:VNUS Medical Technologies, Inc. Files Patent Infringement Lawsuits Against Biolitec, Dornier and CoolTouch 2Health News:The New Condom That Breaks - - - the Mold. 2Health News:Jewel-Osco: 1 Million Reusable Shopping Bags Sold 2Health News:Glaucoma Treatment Can Prevent Blindness 2Health News:Glaucoma Treatment Can Prevent Blindness 3
15 mm curved blade. 8 mm straight distal tip. Serrated on top of knife. Flat handle....
15 mm curved blade. 8 mm straight distal tip. Serrated on top of knife. Flat handle. Designated most popular model or size....
8 mm curved blade. Cutting edge on inside of curve. Flat handle....
For use with N4096 R, N4097 R and N4098 R. 18 mm wide x 167 mm long. Ten per package. Designated most popular model or size....
Medicine Products: