Multiple MRI and nuke products gain FDA clearance

The imaging industry netted 20 product clearances from the FDA last month. Among them were clearances for Marconi Medical Systems

to begin marketing its 1.5-tesla Infinion MRI scanner and for IS2 Research to begin selling its Bi90 digital cardiac gamma camera. A third, received by SonoSite, was for a handheld unit about which the company refused to comment, stating only that the product would be unveiled sometime in the next few weeks.

Also cleared by the FDA was Siemens' Orbiter II gamma camera, a refurbished, software-driven, more user-friendly version of the company's discontinued Orbiter system. Other cleared products include a pulsed-echo ultrasound system, developed by Medge Platforms of New York City; the MXR-2000 mobile x-ray unit built by Irom Imaging of Englewood, CO; and Wilmington, MA-based Visualization Technology's Instatrak image processing system.

The Infinion family of MRI systems was introduced as a work-in-progress during the 2000 RSNA meeting. Marconi already has orders for about 50 of the systems, said Mike Vitagliano, MRI marketing manager for the company. With Infinion, Marconi lays claim to having the world's shortest whole-body system. The magnet is four and a half feet in length, according to product specifications.

"FDA clearance on the (1.5-tesla system) allows us to bring the world's first ultrashort MRI system to market," Vitagliano said.

Infinion is the first high-field product cleared for marketing by Marconi since its Polaris 1-tesla and Eclipse 1.5-tesla models passed FDA muster several years ago. Designed for high throughput, the 1.5-tesla Infinion features a removable patient couch and built-in phased-array spine coil. Capabilities include neuro and orthopedic applications, although the Infinion can be customized for advanced clinical applications such as MR cardiology.

Also cleared by the FDA was IS2's Bi90 digital cardiac gamma camera, dubbed CardioCam, which will be featured at the Society of Nuclear Medicine meeting in June. Built by the company for high-performance cardiac studies, the system performs rest and stress gated single-photon emission computed tomography and biplane gated planar studies. Features include fixed 90¼ geometry, which is designed to ensure that the heart is entirely within the field-of-view. Access to the front of the gantry is open, permitting the use of exercise bicycles or treadmills during biplane gated or first-pass studies.

The end result of the Bi90's technology is markedly improved thallium cardiac images and more confident clinical diagnoses, according to the company.

"Judging from the interest we have seen in only a short while, we expect the unit to quickly become our most popular camera," said Steve Horvath, president and CEO of the Ontario, Canada, company.

Bi90 is an extension of two existing cameras: the NuCamma R+ and NuCamma Rx. The camera is the first of many planned additions to the line, including MammoCam, which will be used as an adjunct to mammography, Horvath said.

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3/28/01, Issue # 1506, page 3.