Navigation Links
Tomophase OCTIS(TM) Receives FDA 510(K) Clearance to Market
Date:12/10/2010

BURLINGTON, Mass., Dec. 10, 2010 /PRNewswire/ -- Tomophase Corporation, developer of the non-invasive Optical Coherence Tomography Imaging System (OCTIS™) and other devices, announced today that it has received FDA 510(k) clearance to market OCTIS.

Tomophase is a leader in the development of OCT brochoscopically-based imaging systems for interventional pulmonology. OCTIS is comprised of a single-use disposable optical catheter and imaging console. Initially OCTIS will be deployed for tissue imaging of airways and lungs, followed by diagnostic and therapeutic applications.

The National Lung Screening Trial (NLST) recently released by the NCI represents an example of how OCT will be applied. In the NLST, the risk of dying from lung cancer was reduced by 20% when the subjects, (>50,000) former smokers, were given low-dose CT scans which resulted in identifying lethal tumors at an earlier, more treatable stage. Tomophase OCTIS has the potential to monitor these patients by imaging pulmonary tissue following a CT scan using laser light rather than radiation.

"We are delighted to receive the 510(k) for our new, novel OCT Imaging System. This clearance reflects the hard work and dedication of our employees and consultants over the past five years. At the present time, there is a lot of excitement in interventional pulmonology due to the emergence of several new innovative, medical technologies and potential applications. Our company is committed to providing new medical imaging products to improve the diagnosis and treatment of diseases of the lung and airways including asthma, emphysema and lung cancer," said Ralph Johnston, President and COO.

Dr. Peter Norris, Chairman and CEO added: "Our first 510(k) represents a giant step forward in our development of OCT technology for interventional pulmonology, heretofore a greatly underserved market. We plan to consistently expand our system's capabilities in order to maximize the potential for safe, cost-effective, optical imaging, diagnostics and therapy for the management of pulmonary disease."

About TomophaseTomophase Corporation is a privately held opto-medical device company with a proprietary position in real-time, high resolution, cross sectional tissue imaging using a variant of OCT. The company is engaged in the research and development of sophisticated fiber-optic catheters and imaging engines, used in conjunction with bronchoscopy, and initially focused on Interventional Pulmonology applications. The OCTIS cross-sectional tissue imaging system is capable of imaging microstructure 2-3 mm below the surface of the airways and lungs to provide valuable visualization information to the physician in the management of pulmonary diseases. Examples of our tissue imaging results are available at http://www.tomophase.com.For further information:Dr. Peter Norris, CEOTomophase CorporationP: (781) 229-5700 x122E: pnorris@tompohase.comRalph Johnston, President, COOTomophase CorporationP: (781) 229-5700 x123E: rjohnston@tomophase.comThis press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.


'/>"/>

SOURCE Tomophase Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical Systems ... "Company"), which develops, markets and sells medical devices and ... , signed a strategic cooperation agreement with Hongyuan Supply ... Supply Chain") on June 20, 2016, to develop Dehaier,s ... strategic cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s ...
(Date:6/24/2016)... , June 24, 2016 According ... by Type (Standard Pen Needles, Safety Pen Needles), Needle ... GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) - ... This report studies the market for the forecast period ... reach USD 2.81 Billion by 2021 from USD 1.65 ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... People across ... in Genome magazine’s Code Talker Award, an essay contest in which patients and their ... award to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... The Grove Investment Group (TGIG), has initiated cultivation and processing operations at its ... Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system ...
Breaking Medicine News(10 mins):