FDA clears Millennium’s Virgo open MRI

A new MRI player hit the market this month when Canadian start-up Millennium Technology received Food and Drug Administration 510(k) clearance for its low-cost open magnet MRI scanner, Virgo. With clearance in hand, Millennium will now begin its marketing efforts.

Established in 1995, Vancouver, BC-based Millennium has developed Virgo from off-the-shelf components obtained from Canada, the U.S., and China. Virgo boasts a 0.35-tesla magnet, requires no cryogens, uses relatively little electricity, and carries an air-cooled gradient system designed to function at 10 mtesla/m, with a rise time of 0.6 msec and a slew rate of 15 mtesla/m per second, according to the company. It can perform most standard MRI exams, including angiography, and the company plans to introduce coils for the head, body, spine, extremities, shoulder, cervical spine, and temporomandibular joint. Its “C” gap enables clinicians to access patients from three sides.

Millennium expects to sell Virgo to small hospitals and clinics as a primary scanner or as a dedicated orthopedic unit. Other uses for the system could be as a secondary scanner to handle overflow, or for specialty applications such as MRI-guided biopsy and intervention or dedicated emergency medicine. Millennium has developed Java-based software for the unit, which it hopes will give Virgo an edge as the industry moves closer to teleimaging.

The company will formally launch Virgo at the upcoming RSNA show, and expects to sell the unit in the U.S. for less than $800,000. The company will focus initially on selling Virgo in the U.S., Canada, China, and the Pacific Rim, and is actively working to extend its distribution networks, particularly in North America. Millennium also plans to continue R&D on dedicated systems for mammography, brain scanning, and veterinary medicine, to expand its product line.