Sep 30 2008
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.