FDAnews
www.fdanews.com/articles/69345-paradigm-medical-granted-ce-mark-for-next-generation-ubm-device

Paradigm Medical Granted CE Mark for Next Generation UBM Device

March 2, 2005

Paradigm Medical Industries has announced it has been awarded the CE Mark for a new generation ultrasound biomicroscope (UBM), enabling the company to market the device in 19 Western European countries and some parts of the Pacific Rim.

"The P60 UBM, which received clearance from RWTUV Systems GmbH, is a fourth generation device that is a very sophisticated microprocessor-based, multifrequency ultrasound biomicroscope that allows users to acquire and view high-resolution images of the anterior segment of the eye," said Paradigm Medical's Chief Operating Officer Aziz Mohabbat. "We expect to begin product sales in Europe immediately."

"The P60 can provide full sulcus-to-sulcus images of the eye in a single pass," Mohabbat added. "Using a precision linear tracking scan head, as well as a B-Scan that produces two-dimensional plane views of the eye for diagnostic evaluation, the P60 represents the state of the art for high-resolution imaging of the eye. Images may be edited and enhanced, printed and saved to mass storage for improved patient diagnosis and record keeping."