News
Optovue announces Bill Jackson joining team as VP of Regulatory & Quality
Experienced senior level regulatory & quality assurance executive, Bill Jackson joins Optovue management team
FREMONT, CA, April 04 – Optovue, Inc. announces that Bill Jackson has joined the company
as VP of Regulatory and Quality Assurance. Bill is a senior level regulatory, clinical and quality
assurance executive with over 30 years of regulatory experience and 25 years in Quality for class
II and III medical device manufacturers. Bill has lead submissions to over 75 countries and was
on the committee that wrote the medical directives in Europe.
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Optovue Receives FDA Clearance of iCam
iCam Non-Mydriatic Color Fundus Camera to be premiered at the Annual Heart of America meeting
FREMONT, CA – February 14, 2013 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), has received 510(k) clearance for its latest product, the iCam™ Non-Mydriatic, compact fundus camera. The iCam camera produces 45° color fundus images of the eye as well as external ocular structures. Even with its compact size, the iCam includes a variety of functions and features that produce high-quality image documentation and management of ocular health. A 12-bit CCD sensor is used to provide deep, rich colors with lower noise than typical 8-bit CMOS sensors used in competing cameras. An LED light source is used for reduced peak light energy to the eye as well as longer life.
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Optovue Receives FDA Clearance of Normative Database for iVue SD-OCT
iVue Normative Database delivers more meaningful clinical analyses
FREMONT, CA – February 8, 2013 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), has received FDA 510(k) clearance of the Normative Database for the iVue SD-OCT system. The Normative Database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and disease. The addition of this diagnostic tool enhances iVue’s comprehensive suite of clinical applications for retina, optic disc, and anterior segment.
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Optovue Announces FDA 510(k) Clearance of the RTVue XR FD-OCT
RTVue XR is being premiered at the Annual Meeting of the American Society of Cataract and Refractive Surgeons
FREMONT, CA, April 23, 2012 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), announces that it has received FDA 510(k) clearance of the XR version of their flagship RTVue® FD-OCT system. Bringing 70,000 A-scans-per-second to spectral-domain OCT, the updated XR version offers clinicians speed that no currently cleared SD-OCT system can match. Together with real-time tracking and the updated SharpVue™ feature, the speed of the RTVue XR can reduce the incidence of motion artifacts while allowing for greater scan averaging output. This results in excellent tissue detail of the retina and choroid layers of the eye. Premiering at the ASCRS in Chicago, RTVue XR is scheduled to be available in the third quarter of 2012.
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Optovue announces David Voris joining team as CFO
Experienced eye care market CFO, David Voris, joins Optovue management team.
FREMONT, CA, March 14th – Optovue, Inc. reports that, after posting a 31% compound annual growth over a four year period, it has hired David Voris as its CFO.
David has more than 25 years of experience as a financial professional, primarily with companies commercializing new products and building sustainable growth in healthcare and life sciences.
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US sales orders for advanced OCT up 32% over previous year
The number of advanced OCT systems sold by Optovue in the U.S. market are up 32% for 2011 over 2010 record levels.
FREMONT, CA, February 28th, 2012 – Optovue Inc., reports that for fiscal year 2011, unit sales of the flagship RTVue® FD-OCT and innovative iVue® Compact SD-OCT are up 32% over the 2010 unit sales level. The company also noted that the December 2011 U.S. sales were yet again at record numbers, surpassing the 2010 December U.S. sales orders.
“Gaining market share in the home country where Optovue manufactures is always satisfying”, stated John Hawley, VP of Domestic Sales. “The mission in 2012 is to continue our market growth world-wide utilizing our new TCP (Total Cornea Power) and VTRAC (Eye Tracking) options; as well as expand our iWellness programs.”
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Optovue Announces Eye tracking upgrade option now available for RTVue FD-OCT
New real-time tracking option for the RTVue FD-OCT provides 30-frames/second tracking of the patients’ retina during scanning posterior structures of the eye.
FREMONT, CA, Feb 1st, 2012 – Optovue Inc., has announced the release of a real-time tracking upgrade for the RTVue Fourier-domain OCT system. Demonstrated at the recent Academy of Ophthalmology meeting, the innovative option is as simple as a software upgrade* to the company’s flagship RTVue FD-OCT (also called SD-OCT) system used world-wide by eye care clinicians to aid in the diagnosis and management of ocular diseases.
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Optovue and Carl Zeiss Meditec have reached settlement in their current patent infringement disputes.
FREMONT, CA, / DUBLIN, CA, January 10, 2012 – Optovue Inc. and Carl Zeiss Meditec Inc. announced today that they have signed a settlement agreement resolving two pending Federal District Court patent infringement cases. Under the terms of the agreement, the companies dismissed all currently pending litigation and entered into a cross-license agreement of certain issued and to be issued patents owned or controlled by each party. The specific terms of the settlement are confidential.
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Optovue Announces FDA Approval for Corneal Power Measurements
Using RTVue® to find a precise measurement of Total Corneal Power (TCP™)
FREMONT, CA; October 17, 2011 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), announces that the RTVue has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Optical Coherence Tomography (OCT) measurements of central corneal power, curvature, and thickness in human corneas, pre- and post-cataract surgery.
The RTVue can be used to calculate the Total Corneal Power (TCP) of the cornea in eyes that have undergone corneal refractive surgery. Furthermore, the RTVue directly measures posterior corneal power and does not rely on good preoperative vision or previous clinical record(s). The success of IOL selection in cataract surgery is largely determined by corneal power. However, corneal refractive power has previously been very difficult to measure in post-refractive patients.
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Optovue Announces FDA 510(k) Clearance for iStand™
New stand adds versatility to the iVue® SD-OCT Device
FREMONT, CA, June 14, 2011 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), announces that the new iStand, a multi-directional stand for universal positioning of the iVue SD-OCT system, received FDA 510(k) clearance in June.
The iStand expands the clinical utility of the iVue SD-OCT device delivering enhanced clinical decisions, procedure planning and documentation. The system enables eye-care professionals to follow patients from diagnosis through post-operative care. By mounting the iVue onto iStand, clinicians can now take further advantage of iVue’s compact size and portability to easily move their OCT between the exam lane, hospital facilities, and satellite offices. The simple, easy-to-use articulating arm facilitates scanning supine patients as well as patients in other positions.
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New! Medicare Reimbursement for SCODI of the Posterior and Anterior Segment
Click on the following links: Medicare Reimbursement for SCODI of the Anterior Segment;
Medicare Reimbursement for SCODI of the Posterior Segment
OPTOVUE ANNOUNCES THE SHIPMENT OF THE 600TH IVUE™ COMPACT SD-OCT SYSTEM
600 Compact SD-OCT shipped for growing international demand
FREMONT, CA, October 4th, 2010 – Optovue Inc., the company that launched the first FDA cleared fourier/spectral domain OCT in the US, announced it has shipped the 600th iVue™ compact SD-OCT system in early September from its Fremont California manufacturing facility.
“We continue to see accelerating growth in the demand for the iVue system, both domestically and internationally,” stated Paul Kealey, Vice President of Marketing for Optovue. “Despite the US launch occurring just recently in June, we are on track to exceed our first year projections on the new compact system. The streamlined GUI, ease-of-use and short “chair time” are helping with patient flow in clinical practices. This functional simplicity, along with the exceptional clinical value of retina, glaucoma and anterior segment imaging as standard features, is proving to be the right combination for the broader eye care market.”
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OPTOVUE Q2 AND FIRST SIX MONTH REVENUE 2010 UP 57% OVER 2009
Continued strong revenue growth for fourier-domain OCT pioneer
FREMONT, CA, September 17, 2010 – Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the US, announced its second quarter revenue results for 2010 grew 57% over the same period in fiscal 2009. This also puts the first six months of 2010 at a 57% revenue increase over the same period in 2009.
“Following our 57% revenue growth in Q1 over prior year, our six month year-to-date revenue growth for 2010 is holding very strong.” stated Gordon Wong, Vice President of Finance for Optovue. “With the recent FDA clearance of the Normative Database for the RTVue FD-OCT system and the strong growth in the sales of iVue compact OCT systems, the remainder of 2010 is on track to significantly exceed forecast.”
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OPTOVUE Announces FDA 510(K) Clearance ON Normative Database
The largest FDA cleared Normative Database for OCT is now available for the RTVue FD-OCT from Optovue, Inc.
FREMONT, CA, September 16, 2010 – Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the US, 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. This is the only normative database taking into account patient age, signal strength of scan, and even optic disc size in certain scan type. These factors along with the large normal sampling offer clinicians a high degree of confidence in our NDB as a reference tool in assessing retina nerve fiber thickness.”
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OPTOVUE Announces FDA 510(K) Clearance for iVue SD-OCT
New compact SD-OCT changes the landscape for imaging once again
FREMONT, CA – May 4/PRNewswire – Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced that the new iVue compact SD-OCT has received FDA 510(k) clearance on April 29, 2010.
“The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have seen very high demand – as expected – in the first quarter,” stated Paul Kealey, Vice President of Marketing for Optovue. “This regulatory clearance for the US market allows us to offer the benefits of advanced OCT imaging to more segments within eye care, where the economic feasibility of the larger systems simply did not work. The iVue begins the next phase of the OCT revolution in the US that started with the RTVue launch in 2006.”
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Optovue Announces 19% Revenue Increase Over FY 2008
Clinical Value and Clinical Utility prove to be the right combination in down economy
FREMONT, CA – April 30, 2010 – Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced fiscal year-end results for 2009 compared to fiscal year 2008. Despite the down economy, eye care clinicians proved that the right combination of clinical utility and clinical value is still the best package.
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Optovue Announces Formation of Eye-Give Foundation for World-Wide Eye Care Philanthropy
US based manufacturer of first FDA cleared FD/SD-OCT to share its success through charity foundation.
FREMONT, CA – April 11, 2010- Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has founded “Eye-Give”, a non-profit foundation for the purposes of donating technology and funding to sight saving charities and organizations around the world.
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Optovue Announces Shipment of the 2000th RTVue Advanced OCT System and 100th iVue Compact SD-OCT Systems
First FDA Cleared SD-OCT System hits world-wide installed mark and smaller companion SD-OCT in high international demand.
FREMONT, CA – April 1, 2010 – Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced a milestone of shipping serial number 2000 of the RTVue fourier/spectral-domain OCT system at the end of February, 2010. Optovue also announced that it has shipped the first 100 iVue compact SD-OCT systems against initial international orders of more than 200 in the first 60 days since the January launch. The iVue compact advanced OCT is currently only available outside the United States in specific countries.
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Optovue announces the hiring of John Hawley as VP of Business Development
Fremont, CA – January 22, 2008 — Optovue, Inc., the first company to introduce a Fourier-domain optical coherence tomography (FD-OCT) system to the US market, today announced that John Hawley has signed on as Vice President of Business Development.
“John has a tremendous amount of experience in a fast growing company environment and an excellent understanding of the eye care market”, stated founder and CEO Jay Wei. “John is well known and respected in this industry, and is a great addition to our management team.”
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Optovue Receives FDA Clearance for Cornea/Anterior Module for RTVue
Fremont, CA — October 25, 2007 — Optovue, Inc., the first company to introduce a Fourier-domain optical coherence tomography (FD-OCT) system to the US market, today announced that on September 28, FDA 510(k) clearance was received for its Cornea/Anterior Module (CAM).
The CAM is an optional attachment for the RTVue, Optovue’s high-speed and high-resolution FD-OCT device for retinal imaging. The CAM add-on enhances the RTVue by enabling five-micron resolution, high-magnification imaging of the cornea, angle and anterior crystalline lens, as well as pachymetry mapping and keratoconus analysis. Together with the retina and glaucoma scanning and analysis functions already provided by the RTVue, the CAM allows the first all-in-one solution for posterior and anterior high-speed, high-resolution OCT imaging.
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RTVue on Good Morning America
BC News Good Morning America interview: “New Tool Could Prevent Blindness – Spectral OCT Helps Doctors Identify Eye Diseases Early.” May 9th, 2007
http://abcnews.go.com/GMA/OnCall/story?id=3155121&page=1
Optovue, Incorporated Secures $10.5 Million in Series B Funding Led by Trevi Health Ventures
Fremont, CA – March 21, 2007 – Optovue, the first company to introduce a fourier-domain, optical coherence tomography system to the US market, announced today that the Company has secured $10.5 million in Series B funding. The investment was led by Trevi Health Ventures, the venture capital firm focused on medical devices, biopharmaceuticals and healthcare services with office in New York and London.
Acorn Campus, iD Soft Capital, H&Q Asia Pacific, Harbinger Ventures, and the lead investors in Optovue’s Series A round, also participated in the Series B financing. Since Optovue’s Series A funding in 2004, the founders and development team have successfully launched their first product and completed a long-term strategic product development plan that will enable Optovue to become the industry leader for the development of new innovated technology for the eye care market. Read more ……
For further information, please contact:
Jay Wei
President/CEO
Paul Kealey
VP Sales & Marketing
Optovue Receives 2007 Medical Design Excellence Award
Optovue Receives Bottom Line Design Award
Optovue Receives Bottom Line Design Award. The feature story “World’s 11 Coolest Products,” has posted this morning on CNNMoney.com, and was one of “Top Stories” on CNN.com as of noon EST which will lead to great coverage of the story! It is the headlining article on the Business 2.0 site. February, 2007 http://money.cnn.com/ http://www.bottomlinedesignawards.com/2007/winners/optovue-rtvue.html
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