FDA approves Fonar open scanner

Fonar introduced its “Open Sky” scanner room two years ago at the Radiological Society of North America meeting, and this month the Melville, NY-based company moved one step closer to putting the system on the market.

The Food and Drug Administration has given Fonar premarket approval for the Fonar 360, which is the platform scanner for the Open Sky. The Fonar 360 will have a 0.6-tesla field strength.

Fonar says the company has ushered in a new era of patient friendliness in MR with its work-in-progress Open Sky room. Patients will walk into the scanner room in which two circular structures projecting from the ceiling and floor are the only objects. There’s nothing else—no posts, no tube they must climb into—between the patient and the scanner room walls.

The walls are decorated with a landscape scene, and the room is quiet thanks to Fonar’s patented sound-dampening system. Patients will also be able to choose which landscape setting they would like. The large circular structures that the patient sees as part of the landscape are the poles of the scanner’s magnet.

Last year, healthcare services contributed more to Fonar’s revenue than scanner sales.

During its 1999 fiscal year (end-June), Fonar posted revenue of $36.9 million, a 34% increase over 1998’s $27.6 million, but also sustained a net loss of $14.2 million. Fonar attributed the loss to low scanner sales and expenses related to the R&D of four new MRI products (SCAN 11/10/99). Fonar believes that its new scanners, including the Open Sky, will lead to sales growth (SCAN 3/3/99).