MR leads latest pack of devices clearing FDA

March 6, 2002

January performance tops past two yearsRadiology turned in a strong performance in January with FDA reviewers clearing 25 products in this class. The numbers break with recent experience, as the first month often marks the low

January performance tops past two years

Radiology turned in a strong performance in January with FDA reviewers clearing 25 products in this class. The numbers break with recent experience, as the first month often marks the low point for the year, coming off typically high-volume Decembers. This pattern has repeated in each of the last two years: the FDA cleared just 15 radiologic devices in January 2000 and 18 a year later.

Radiology's typically poor showing in January is usually followed by a strong February. Whether February can hold its own this year may already be foreshadowed. On Feb. 1 (the most recent day available at press time), FDA reviewers had already cleared five radiologic devices.

By law, the agency has 90 days to review devices submitted for 510(k) review. Reviewers met or beat their deadlines for each of the 25 devices cleared in January. Just six of the devices were submitted to the FDA in October. The majority, 14, were submitted in November, four in December, and one in January.

MR dominated, racking up eight of the 25 clearances compared with four each for ultrasound, radiotherapy, and x-ray; two for image management; and one each for nuclear medicine and CT. The remaining product refused to fit into any of the common categories-a tomographic device that uses optical coherence to examine structures in the back of the eye.

MR's strength was due in large part to the clearance of five coils. USA Instruments was okayed to market its Premier III Phased Array CTL spine coil for use on GE's 3T scanner. USA Instruments also received clearance for two coils (extremity and body) for use with Siemens' 1T open Rhapsody scanner. (Rhapsody passed the FDA in January 2001 but has not yet entered mass production.) MRI Devices got the nod for a pediatric head and spine coil. Philips Medical was cleared to sell its transmit/receive quadrature body coil for the Intera 3.0T system. (Philips is now gearing up to begin selling the very high field whole-body system, which cleared the FDA in December 2000.)

Two MR scanners cleared the FDA in January. GE's Signa Infinity is a modification of the Signa Twinspeed. The company added eight independent receive channels and updated the computer subsystem, as well as the radio-frequency pulse control subsystem. Philips' Infinion 0.6T is the company's first higher field open scanner. Company plans called for a global launch of the product March 1 at the upcoming European Congress of Radiology in Vienna.

Also clearing the FDA was a computerized tissue segmentation system. Developed by Confirma, the system-called Accent-analyzes pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition algorithms to help physicians interpret MR images for both screening and diagnosis. The proprietary software, which runs on a standard PC, may also be used to measure anatomical structures.

The sole nuc med product was developed by IS2, a gamma camera designed specifically for clinical study of the breast. The product has two rectangular heads mounted on a gantry optimized for mammography.

The only CT product to pass the FDA was Voxar's calcium scoring package. The two image management products were a flat-panel display from Barco (Coronis 3MP) and a laser imager (DryPro 751/752) from Konica.

Among vendors of x-ray based systems, Canon USA got the nod for its CXDI-31, a portable digital flat panel (SCAN 2/6/02). Planmed was given the go-ahead to sell its Sophie and Sophie Classic systems (SCAN 1/12/02). Also passed was the Fluoroscope Image System from 3D Sharp. The stand-alone computer system interfaces with fluoroscopes using a video cable, frame grabbing and enhancing images for display on the computer at the same time as the original image appears on the fluoroscope monitor. The product, designed as a retrofit for existing fluoroscopes, promises improved image contrast and brightness and reduced random noise.

Radiotherapy devices include an absorbable spacer for brachytherapy seeds, a radiation therapy planning system, and a stereotactic immobilizer for patient positioning. The standout was TomoTherapy's Hi-Art, an integrated system for the planning and delivery of intensity-modulated radiation therapy (IMRT). The system is designed to deliver precise doses of radiation to tumors while minimizing collateral exposure of healthy tissue. Hi-Art calculates the treatment plan for physician review and approval. This plan is then implemented at the Hi-Art operator station. Using the onboard linear accelerator as the radiation source, treatment begins with a CT scan. CT images confirm or provide the basis for changing patient position to match the therapy plan. Hi-Art is then used to treat the patient according to the plan, delivering prescribed radiation from a 6-megavolt linear accelerator in a helical pattern using IMRT.

Among the ultrasound systems was a pulsed Doppler system from Philips. The new product, dubbed M2540, can be equipped with a wide array of transducers, 19 in all, including nonimaging pencil transducers, curved linear array, linear array, and sector and endocavitary probes. The agency cleared a handheld ultrasound product developed by Tetrad that features five transducers.

GE Medical won clearance for two additions to its Logiq family. Logiq 5, a shared services system, can be equipped with up to 10 transducers, including ones for endocavitary and intraoperative applications. Logiqbook is a portable system featuring an integrated keyboard, fold-up liquid-crystal display, and interchangeable electronic array transducers. The system, which GE splashed across the Olympics in television ads running during the games, is comparable to the company's low-end B&W Logiq 100. Logiqbook was cleared for use with six transducers. Transvaginal and transrectal scanning are each supported by one.