FDA clearances rebound in July, reach close to year's record level

Early look at August indicates continuing trend

The radiology industry is riding a wave of good news from the FDA. The number of devices receiving clearance for marketing in the U.S. shot up to 30 in July, and a preliminary look at the FDA database for August indicates that at least as many were cleared in that month.

These latest rises are the leading edge of a roller-coaster ride that has manufacturers reeling from the year's record high of 31 in May, a drop to 20 in June, and a return to stratospheric levels.

MR dominated in July, with eight of the 30 clearances. This was followed by ultrasound with seven and image management, which garnered six. Radiotherapy and x-ray accounted for three each, nuclear medicine two, and CT one.

Two notable MR submissions were a high-field dedicated mammography system and an analysis package. The MR scanner from Aurora Imaging Technology is a ramped up version of the Aurora system the FDA cleared in 2001. Field strength was boosted to 1.5T from 0.5T, and the radio-frequency system and spectrometer were changed to operate at the required higher frequencies. The system is optimized to display the breast, axilla, and chest wall tissue local to the breast. It offers 2D spin-echo, 2D/3D gradient-echo, and fat-suppression imaging.

GE Medical Systems obtained FDA clearance for its Delta software option, an analytical software tool designed for the review and reporting of cardiac MR images. Delta can import and display MR images as parts of multiple studies or as a series of multislice, multiphase images. Multiphase sequences of images can be displayed in cine mode. Tools on the report interface allow point, distance, area, and volume measurements, such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

The company named as predicate devices MRI-FLOW and MRI-MASS, two products developed by Medis Medical Imaging Systems and distributed by GE. The FLOW analytical package renders measurements over a cardiac cycle, typically with fewer than 10 seconds of processing time. MASS quantitates multislice/multiphase left and right ventricular functions.

X-ray and CT standouts were a class unto themselves, as both addressed bone densitometry. Image Analysis of Columbia, KY, received clearance for DXAView Hip and Spine, which is composed of software options for the company's QCT (quantitative CT)-3D Plus product. QCT-3D Plus provides 3D projection measurements similar to conventional dual x-ray absorptiometry. The options estimate bone mineral content and bone mineral density of the proximal femur and spine. DXAView uses phantom calibration by QCT. Calculations are performed on volumetric images obtained with conventional CT protocols and radiation doses.

GE Lunar's DPX series Bravo, Duo Bone Densitometer estimates BMD of the spine, femur, and forearm. The DPX Duo can be used as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table. The DPX series Bravo, Duo Bone Densitometer performs a 90-second scan, with a total skin x-ray exposure of 2.0 mrem per measurement, which is comparable to the Prodigy and DPX-L bone densitometers previously developed and now on the market.

Dymax of Pittsburgh got the go-ahead from the FDA to market the Site-Rite IV pulsed-echo ultrasound system, a lightweight, low-output, B-mode ultrasound scanner designed primarily to help clinicians achieve vascular access to major veins, arteries, and organs. The scanner, which allows high-resolution imaging as deep as 18 cm, can be used at the bedside as well as in emergency rooms, operating rooms, angiography suites, catheterization laboratories, and intensive care units. The portable system operates on battery or AC power and utilizes proprietary probes with frequencies ranging from 3.5 to 9.0 MHz.

Several substantial product enhancements will likely follow FDA clearances in ultrasound. These include a Siemens upgrade of its Sequoia, including transducers and software packages that promise improved visualization, as well as GE's upgrade of the Logiq 7. A prime modification on the Logiq 7 is the user interface, which includes specialized controls and a color video CRT and LCD touch panel.

Among the nuclear medicine submissions to clear the FDA was a new PET/CT, the Gemini 16 from Philips Medical Systems. The product combines a high-performance PET scanner with the company's 16-slice Mx8000IDT. The system integrates the two operator consoles into a single workstation. PET and CT components can be used either integrated or as stand-alone systems. Individual gantries remain intact, although major subsystems are located within a common integrated housing. PET and CT images are registered and overlaid by fusion software.

Two workstations and a digitizer rate special mention in the image management group of newbies. Electromed Imaging of Laval, Quebec, won FDA clearance for its Cardio Vascular Information Enhanced Workstation, also called CVIEW, which displays images from cardiac cath, echo, and angio suites. CVIEW accepts DICOM 3.x CDs or can be configured to read DICOM 3 images from an archive server.

Maxxvision of Gainesville, FL, has clearance to begin marketing a handheld digitizer designed to enhance mammographic film. The device digitizes a portion of the film, processes the data, and displays a magnified view on an adjacent monitor.

Philips can now ready ViewForum 2003 for commercialization in the U.S. The software receives images from scanners, such as CT or MR, or from image archives, allowing image manipulation, communication, and printing, as well as quantification. The package is designed to run on standard PCs but will also be available as a plug-in version for use on modality workstations.