Industry FDA clearances set record in 2006

February 6, 2007

The imaging industry in 2006 beat the previous year’s record number of FDA clearances, tallying 360 compared with 349 in 2005. Vendors scored 34 in September and 25 in October before surging with 46 clearances in November, then finished the year with 28 in December.

The imaging industry in 2006 beat the previous year's record number of FDA clearances, tallying 360 compared with 349 in 2005. Vendors scored 34 in September and 25 in October before surging with 46 clearances in November, then finished the year with 28 in December.

Topping the list of clearances was Siemens Medical Systems' dual-energy CT, which debuted at the 2006 RSNA meeting. This technology, which leverages two individual x-ray beams at different spectra, provides information about the chemical composition of energy-dependent body materials. Postprocessing of CT images acquired simultaneously at two different kVp levels is orchestrated by syngo Dual Energy.

Spectrum Dynamics' D-SPECT Cardiac Scanner System cleared the FDA in late October. The dedicated cardiac gamma camera uses no external moving parts. Rather, sensors rotate within its closed detector head. The special scanning geometry and detector technology enable shorter scan times, according to the company. The system is designed to use radiofrequency ID tags attached to both the patient's wrist and the syringe containing the radiopharmaceutical to ensure positive identification of patient and syringe.

A PC-based Linux workstation, dubbed Visualase Envision by its developer BioTex, retrieves and processes data from compatible MR scanners, facilitating near-real-time analysis of dynamic MR scans. The software analyzes either changes in image intensity, useful in dynamic contrast enhancement studies, or temporal changes, as in phase-contrast angiography. Analyzing temporal changes is also useful in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data can be manipulated and viewed in different ways, allowing the monitoring and display of data at selected points over time.

Chinese ultrasound provider Shenzhen Mindray Bio-Medical Electronics received the go-ahead in December to start marketing a high-end general-purpose ultrasound system comparable to Toshiba's Nemio, Philips' iU22, and Siemens' Sequoia 512. The DC-6 Diagnostic Ultrasound System operates in B-, M-, color, pulsed-wave, and power modes, employing an array of linear and convex linear probes ranging in frequency from 2.5 MHz to 12 MHz.

Two MR coils merit special note: a 3T flex coil for Siemens' Trio and the eCoil Imaging System by Medrad. Siemens' Flex Loop Coil Set 3T consists of five receive-only coils - two four-channel and three linear polarized flexible coils - and one interface, which contains the preamplifiers, cable traps, and a combiner network. Medrad's eCoil Imaging System, designed for Philips MR scanners, is a receive-only coil intended for high-resolution imaging and spectroscopy of the human colon, cervix, or prostate, as well as surrounding pelvic tissue. The eCoil interface allows the use of Medrad disposable endorectal coils.