FDA clearances rise in February to surpass previous year’s pace

So far this year, the regulatory agency has cleared 53 radiological devices, 18 more than the number cleared in the first two months of 2004. Last year’s performance is significant in that the FDA cleared more devices (349) than in any year since SCAN began keeping records of FDA clearances in 2000.

Ultrasound accounted for almost a third of the 25 devices cleared by the FDA in February, well ahead of last year's record-setting pace.

So far this year, the regulatory agency has cleared 53 radiological devices, 18 more than the number cleared in the first two months of 2004. Last year's performance is significant in that the FDA cleared more devices (349) than in any year since SCAN began keeping records of FDA clearances in 2000.

Seven image management and six MR devices accounted for most of the remaining February clearances. Radiotherapy and x-ray equipment each accounted for two.

Particularly noteworthy among the eight ultrasound devices cleared by the FDA were five new systems. The GE Logiq Twin is a compact portable device with integrated keyboard, fold-up LCD type display, and interchangeable electronic-array transducers. It measures 34 cm wide, 29 cm deep, and 6 cm high. It is intended for fetal and obstetric as well as gynecological and urological imaging. Also addressed are pediatric, small organ, cardiac, intraoperative, and endocavitary applications. GE refused to explain how the Twin differs from its predecessor, the Logiq Book, deferring to an announcement in the months ahead.

The Esaote 7350 Ultrasound Imaging System is a full-sized shared services device, offering standard imaging features, including Doppler and color flow mapping, as well as tissue enhancement imaging and lower frequency probes. The 7350 is designed to drive phased, convex, and linear array probes.

The Sonalis Platform System from Boynton Beach, FL-based 3G Ultrasound is a software-controlled ultrasound system optimized for prostate and rectal wall studies. It supports linear and curved linear arrays.

Toshiba America's Xario is a general-purpose mobile system. It employs sector as well as flat and convex linear arrays with frequencies ranging from 2 to 12 MHz.

Model 850 XTD from Fukuda Denshi is intended for shared services. It can be configured with a color CRT or LCD.

PACS developer RealTimeImage modified its iPACS Prism to allow the display of digital mammograms. The modular iPACS Prism 5.0 will be offered under different brand names, according to the FDA filing, depending on customer implementation and component selection.

Innovative Magnetic Resonance Imaging Systems upgraded its ceiling-hung MR scanner to a new version, called the Neuro II-S. In its FDA filing, the Canadian company, based in Calgary, AB, noted that the system can be used to image the whole body. It is optimized, however, for intraoperative applications stemming from neurological interventions. The Neuro II-S, like its predecessor, is suspended from an overhead gantry (SCAN 4/25/01). The bore of the magnet moves toward and away from the patient on the table.

Shimadzu, which in recent years has focused U.S. efforts on x-ray equipment, obtained clearance to market a surgical mobile C-arm. The system supports fluoroscopy and radiography.