Caliber Imaging & Diagnostics, Inc. Announces FDA 510(k) Clearance for its VIVASCOPE System
Published: May 15, 2018
BOSTON, May 15, 2018 /PRNewswire/ -- Caliber Imaging & Diagnostics Inc. (Caliber I.D.) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for modifications to its VIVASCOPE® System. The VIVASCOPE System is an industry-leading reflectance confocal microscopy (RCM) device that allows dermatologists to non-invasively visualize cellular structures within the skin.
A non-destructive in-vivo imaging modality, the VIVASCOPE System painlessly provides high-resolution RCM images of the epidermis down to the supporting stroma in thin, optical slices. The recent modifications to the system include refined ergonomics and improved imaging capabilities.
"This FDA clearance is another important milestone for Caliber I.D. and its VIVASCOPE System," said L. Michael Hone, CEO of Caliber I.D. "Caliber I.D. is committed to providing the highest quality and the most reliable products to its customers and their patients."
For more information about the VIVASCOPE System, click here.
About Caliber Imaging & Diagnostics, Inc.
Caliber Imaging & Diagnostics, Inc. is a global leader in the design and manufacture of in-vivo and ex-vivo confocal microscopy equipment for the medical device, clinical research and life science industries. Headquartered in Andover, Massachusetts, Caliber I.D. has more than 20 years of experience specializing in confocal microscopy. Caliber I.D.'s VIVASCOPE System product portfolio has been featured by more than 800 publications. For more information about Caliber I.D. and its products, please visit www.caliberid.com.
VIVASCOPE is a registered trademark of Caliber Imaging & Diagnostics, Inc.
Caliber Imaging & Diagnostics, Inc.
Director of Clinical Marketing
SOURCE Caliber Imaging & Diagnostics, Inc.