July FDA clearances continue red-hot pace

August 11, 2006

The news keeps getting better on the regulatory front. The imaging industry in July added to its already extraordinary record of FDA clearances for 2006, boosting the year’s tally by 32 to 200 premarket notifications.

The news keeps getting better on the regulatory front. The imaging industry in July added to its already extraordinary record of FDA clearances for 2006, boosting the year's tally by 32 to 200 premarket notifications.

In the six years DI SCAN has tracked FDA 510(k) clearances, it's the first time vendors have reached this mark this early in the year.

Ten of the July clearances involved radiation therapy. Six addressed ultrasound. MR and image management each had five clearances, followed by x-ray with four and CT with two.

Ultrasound had several potentially significant clearances. Three involved GE Healthcare, which now has the green light to market its Logiq Twin, a portable general-purpose system comparable to the company's Vivid-i with integrated keyboard, fold-up LCD-type display, and interchangeable electronic-array transducers. In transport mode, it measures 34 cm wide, 29 cm deep, and 6 cm high.

GE is also cleared to market the Voluson E8, a full-featured general-purpose system in the same class as the GE Voluson 730 Pro/Expert. The new configuration provides additional probe options, improved user interface, and overall quality and image enhancement, according to the FDA submission. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touchscreen, and color 15-inch LCD image display.

Siemens has the FDA's nod to sell the Acuson X300, a high-performance, general-purpose, software-controlled system featuring a flat-panel display. For regulatory purposes, the company said the X300 is similar to several other Siemens scanners, namely Sonoline Antares, Sonoline G 60 S, Sonoline Orchid, and the Acuson CV70.

Among the MR highlights was a coil developed by InSightec to target high-energy ultrasound to lesions in the breast and other medium-sized anatomical regions, including the spine, neck, shoulder, thigh, foot, ankle, and joints. The receive-only radiofrequency coil, compatible with GE's Signa scanners and providing a 15-cm field-of-view, consists of two 6.5-inch loops located one above the other and electrically connected in parallel. One version of the MRgFUS coil operates at 1.5T, the other at 3T. The MRgFUS coil is specially designed to operate with a focused ultrasound (FUS) treatment employing MR thermometry to monitor tissue temperature.

In x-ray, Ziehm imaging received clearance for its Vario 3D and Vision FD mobile C-arm systems. The new products support diagnostic, interventional, and surgical procedures (DI SCAN 8/10/06, Ziehm Imaging readies push into U.S. C-arm market).

In image management, Siemens has the go-ahead to market its syngo MultiModality Workplace, designed to support several modalities and different combinations of clinical applications. Applications can be added either individually or as clinically focused packages. It can be configured as a stand-alone diagnostic review and postprocessing workstation to assist in diagnosis, as well as surgical planning, interventional procedures, and treatment planning.

Siemens will extend its Expert-i technology, initially proven in MR, to CT with the clearance of this option by the FDA. With this version of Expert-i, remote users will be able to log onto the syngo MultiModality Workplace from inside the local area network.

Also in CT, GE received premarket notification on its LightSpeed 7.1, an advanced version of its 32- and 64-slice CT platform that adds new application features, according to the FDA submission.

In radiation therapy, Direx Systems can begin selling its Magis 1 and 2 add-on mobile imaging systems designed for coupling to the gantries and couches of linear accelerators. MAGIS acquires and processes stereoscopic images to identify discrepancies between planned and actual target positions.