Apr 27 2010
Digirad Corporation (NASDAQ: DRAD), a diversified health care company specializing in the early detection of disease to enhance quality of life, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), enabling the Company to market and distribute its ergo™ large field-of-view, general-purpose portable imaging system.
Digirad's ergo marks the beginning of a new era of freedom for nuclear medicine. The advent of a large field, solid-state portable general-purpose camera that makes it possible to "image without boundaries" for such a diverse range of procedures is a significant breakthrough for the nuclear specialty. The ergo's unique ergonomic, lightweight portable design enables imaging to be performed in the nuclear department and outside (ICU, CCU, OR, ER, pediatrics, trauma units, patient floors, ambulatory services, women's health or research areas). To top it off, the ergo expands clinical utility and performance to a level that was until now, not possible. The ergo applies breakthrough solid-state technology in a manner that delivers real gains in patient comfort, clinical flexibility and diagnostic quality.
Digirad CEO Todd P. Clyde stated, "The ergo system is an important milestone in our strategy to expand our business in the hospital sector by introducing a series of advanced solid-state cameras that are distinguished by their ability to deliver higher clinical value and return on investment than conventional photomultiplier-based camera technologies generally in use today. The ergo provides institutions with the means to dramatically reduce costs for many procedures, improve patient satisfaction, raise productivity and flexibility, and the capability to generate revenues from new procedures -- all critical considerations for hospitals today."
The heart of the ergo is its large 12.25 inch by 15.5 inch field-of-view, Digirad's most advanced solid-state detector technology ever. The system delivers unsurpassed performance specifications for general imaging with intrinsic spatial resolution of 3.25 mm, energy resolution of 7.9% and count rate capabilities of 5 Mcps. The end result is consistent outstanding quality nuclear studies for every patient -- everyday. The ergo's unique design features three compound detector motions and a portable base to introduce a level of detector positional flexibility, unmatched by any other system. Digirad plans to ship its first production systems beginning in June of this year to a number of leading medical centers in the US and abroad.
Clyde concluded, "The ergo represents a whole new level of freedom both within the nuclear department and outside. The expanded clinical flexibility the system affords introduces exciting new imaging possibilities for a wide variety of procedures. The cost, size and flexibility of the ergo system will be attractive to institutions seeking innovative ways to improve quality, increase productivity and improve patient care."