BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Lucid Receives FDA Clearance to Market Its VivaScope(R) Reflective Confocal Microscope System in the U.S.


9/30/2008 6:25:46 AM

ROCHESTER, N.Y.--(BUSINESS WIRE)--Lucid, Inc. today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its VivaScope® System. VivaScope confocal imagers provide noninvasive, in vivo cellular resolution images of skin and are now specifically cleared “…for review by physicians to assist in forming a clinical judgment.” The VivaScope System, in conjunction with the Company’s VivaNet® telemedicine network, allows medical images of skin to be acquired, stored, retrieved, displayed and transferred for near-real-time collaboration among physicians. The Company plans to implement clinical VivaScope System beta sites in the U.S. beginning in the fourth quarter, with a Mid-Atlantic regional launch beginning in the first half of 2009.

“This clearance is an important milestone in expanding the clinical application of Lucid’s VivaScope System in the U.S. and supports our goal of widespread acceptance of the technology in the dermatology market,” said Jay M. Eastman, CEO of Lucid. ”The 510(k) clearance opens use of the images produced by our state-of-the-art VivaScope medical devices for review by physicians so that they can form accurate clinical judgments regarding the dermatological condition of a patient’s skin. Previously, as FDA Class 1 devices VivaScopes were contraindicated for use as ‘a primary means of diagnosis’,” Mr. Eastman added.

“Typically in the U.S. 40 to 50 skin biopsies are performed before one melanoma is detected,” Mr. Eastman continued. “Images from our VivaScope Systems are routinely used by melanoma experts in Europe and Australia to reduce the need for painful, invasive skin biopsies and drastically reduce the time required for diagnosis and treatment of melanoma and a variety of skin conditions.”

A VivaScope System may consist of a VivaScope 1500 confocal imaging head, a VivaScope 3000 imaging head, or both. The VivaScope 1500 is Lucid’s second-generation in vivo confocal imager, designed for routine clinical examination of the skin. The VivaScope 3000 is the world’s first handheld confocal imager, and can more easily access those areas of the skin that may be difficult to image with the 1500. The VivaScope cellular imagers, coupled with the Company’s innovative VivaNet medical information system are designed to allow secure, HIPAA-compliant, near-real-time collaboration between dermatologists and other medical specialists, including pathologists, thereby improving care for patients.

The use of reflective confocal microscopy in numerous clinical applications has been validated by more than 130 case and clinical studies published in peer-reviewed scientific and medical journals. A comprehensive list of these publications can be found at the Company’s Web site www.lucid-tech.com.

About Lucid

Lucid, Inc. is a medical device and information company with offices in North America, Europe and Australia. Lucid is dedicated to providing improved care for dermatology patients by coupling its noninvasive VivaScope® cellular imaging technology with its innovative VivaNet® medical information system to allow secure, HIPAA-compliant, near-real-time collaboration between dermatologists and other medical specialists. The VivaNet® system provides rapid online medical image transfer, storage and retrieval, thus enabling these critical collaborative consultations. The technologies delivered by Lucid provide images that physicians use in forming critical clinical judgments in cases of dermatologic disease, while ensuring patient comfort and piece of mind.

VivaScope® and VivaNet® are registered trademarks of Lucid, Inc.

Contact: Lippert/Heilshorn & Associates, Inc. Kim Sutton Golodetz (investors) 212-838-3777 Kgolodetz@lhai.com or Bruce Voss 310-691-7100 Bvoss@lhai.com or Jules Abraham (media) 212-838-3777 Jabraham@lhai.com or Lucid, Inc. Jay M. Eastman, CEO 585-239-9800 or Marcy Davis-McHugh, Corp. VP 585-239-9800 corp@lucid-tech.com

Source: Lucid, Inc.

Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES