August FDA clearances surge

October 20, 2006

The imaging industry tallied another 27 FDA clearances in August, the most recent month for which detailed accounts are available. The month's clearances drive the running count for 2006 to 227. If vendors maintain this pace, they will likely beat last year's record 349, as the clearances in the final quarter of the calendar year are generally high.

The imaging industry tallied another 27 FDA clearances in August, the most recent month for which detailed accounts are available. The month's clearances drive the running count for 2006 to 227. If vendors maintain this pace, they will likely beat last year's record 349, as the clearances in the final quarter of the calendar year are generally high.

Image management led all categories with seven devices followed by ultrasound with six and x-ray with five. MR and radiation therapy each had three devices; nuc med, CT, and ultrasound each had one.

Heading the lineup in nuclear medicine is Philips Medical Systems' Apollo Gamma Camera, which may eclipse the company's Forte system. Among the new features built into Apollo are: Caudal/Cephalic Imaging; a low-energy high-resolution collimator with enhanced sensitivity, a new central high-sensitivity region collimator, a larger field of view made possible by square-cornered detectors, a thicker detector crystal (3/4- rather than 5/8-inch), improved automatic body contouring, "MegaBody Mode Imaging," a nine-axis ring gantry, an extra-large patient bore, and a cart-based semiautomatic exchanger (see related article posted Oct. 20 for details).

In MR, Imris of Winnipeg, MB, cleared an enhanced version of its ceiling-hung MR scanner. The Neuro II-SE system is composed of Siemens' traditional MRI unit, the Espree - including diagnostic coils - the company's own "Magnet Mover System," the OR Table Assembly, and the Intra-Operative Coil Kit.

CorTechs Labs gained FDA clearance for its NeuroQuant, which is designed for labeling, visualization, and volumetric quantification of segmentable brain structures, utilizing a set of MR images. This software automates the currently manual processes.

In ultrasound, Ultrasonix Medical is cleared to release its Sonix ultrasound system, described for the FDA as a highly mobile software-controlled diagnostic unit capable of real-time compounding and harmonic imaging. The system is equipped for electrocardiography and fetal biometry.

Siemens has the green light to market its general-purpose Acuson X500.

In digital radiography, Canon got the go-ahead for its CXDI-40EC digital x-ray detector. This detector uses amorphous silicon, as does Canon's already available CXDI-40EG. The newly cleared CXDI-40EC, however, uses a different material for the fluorescent screen deposited on the silicon coating, according to the FDA document. The new CXDI-40EC uses cesium iodide, whereas CXDI-40EG uses gadolinium oxysulfide. The use of cesium iodide almost doubles the DQE possible, according to the document, which allows the detector to deliver diagnostic images with about half the x-ray dose required by CXDI-40EG.

GE is cleared to begin selling its new 9900 Plus mobile C-arm fluoroscopy system, although its commercial release may be delayed by regulatory problems at the company's Salt Lake City manufacturing facility (see DI SCAN 10/18/06, GE-OEC suspends surgical C-arm shipments). The GE-OEC 9900 Plus C-arm with its flat-panel digital detector is intended to replace systems built around image intensifiers, according to the FDA document. It is designed to support diagnostic, surgical, and interventional procedures, including cholangiography, as well as endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical-care, and emergency room procedures. A 3D software option reconstructs volumetric images acquired using rotational fluoroscopy. The surgical navigation feature helps locate structures during open and percutaneous procedures.

In CT, Xoran Technologies can market its xCAT, a compact system featuring a gantry designed to accommodate the head, neck, wrist, ankle, hand, and foot. The building blocks of xCAT are a motorized scanning arm carrying an x-ray source and image detector and a computer running xCAT software. The system reconstructs 2D and 3D images, which support anatomical measurements. Images can be exported via Ethernet or through the use of optical media or a memory stick.