FDA clearances lag behind last year’s pace

November 6, 2007

As the end of the year closes in, vendors find themselves trailing far behind the previous year in the number of devices cleared by the FDA for marketing in the U.S.

As the end of the year closes in, vendors find themselves trailing far behind the previous year in the number of devices cleared by the FDA for marketing in the U.S.

As of Sept. 30, vendors had gained FDA clearances on 211 radiological devices compared with 255 in the year-earlier period. Not since 2002, when the FDA had cleared only 202 devices in the first three quarters of the year, has the number been lower.

This year started slowly, as vendors in the first quarter cleared fewer imaging devices than during any other quarter in the seven years during which DI SCAN has tracked them. In the first quarter 2007, just 55 devices won 510(k) clearances.

Vendors will need a big finish this year, in the neighborhood of 150 clearances, if they are to approach last year's final tally of 360. In the meantime, several notable devices are among those recently cleared.

A digital radiography system, EOS, from French developer Biospace med, incorporates two sets of xenon gas-filled digital detectors and x-ray tubes operating singly or together. The system generates frontal and lateral images of the patient either standing or sitting. EOS is not designed for the evaluation of lung nodules or use in fluoroscopy, angiography, or mammography.

A general-purpose ultrasound system from Chinese manufacturer Shenzhen Mindray can handle freehand 3D imaging and panoramic scans. The new product, DC-6, uses linear, phased, and convex array transducers with a frequency range of 2 to 12 MHz.

Riverain's FirstView is a dedicated server for managing chest radiographs and computer- aided detection results. The workstation acts as an interface with the CAD component, if installed or available at the clinical site, and displays information contained within the DICOM header of the images.

Hitachi's ECLOS CT system collects up to 16 slices of data per rotation operating in a helical scan mode.