FDA clearances drop back to normal range in June

Image processing software provides highlights

The number of radiological devices clearing the FDA returned to earth in June. Reviewers at the watchdog agency passed just 20 radiological products for marketing in the U.S., down from the extraordinary surge of 31 clearances in May. The June number was more in line with the expected total, as the agency had cleared 20 and 22 that month in 2002 and 2001, respectively.

Recent graduates from the regulatory process were split about evenly over several categories. Nuclear medicine had four. X-ray, image management, and radiotherapy had three each. MR and ultrasound had two each. One device cleared by the radiology panel is used in spinal fusion surgery.

Notable among the MR devices is MR image processing software called 3TP from a New York City firm of the same name. The software supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The time course information can be displayed in different formats, including a parametric image overlaid onto source MR images.

Recently cleared AutoBone stands out in the CT category. Developed by GE, AutoBone is an optional software extension of the Volume Viewer application of the company's Advantage Workstation version 4.1 and higher. It can be used to facilitate visualization of vessel features and to assist in segmenting bony structures from abdominal and extremity CT angiography data sets.

Two clearances in nuclear medicine merit special attention. The Virgo system is a gamma camera developed by Diagnostic Development of Horsholm, Denmark. The system includes two fixed 90 degrees dual-head detectors and a patient chair that reclines into a slanted position for the examination. Virgo is designed primarily for cardiac applications.

Philips received clearance to begin marketing an ultrahigh-energy collimator for cardiac imaging. The 300-pound device, designed for positron imaging, is compatible with two of the company's dual-detector systems: the Forte and Vertex gamma cameras.

Philips also received clearance to market the EasyDiagnost Eleva, a multifunctional radiography and fluoroscopy system. The conventional film-based product includes a floor-mounted tilting patient support table and tilting spot-film device integrated with a four-mode image intensifier and TV camera. The system optimizes workflow by converting patient data from the RIS into system parameters. It can be configured with generators from Philips' Velara family, with digital spot-film cameras from Philips' DI family, and with a Philips ViewForum workstation. An optional dedicated ultrasound system, the Ultramark 400C, can also be added.

The EasyDiagnost Eleva can handle patients weighing up to 400 pounds, an increase of 30% compared with the previous version. Adjustments for variations in patient size are automatically made based on patient age, weight, and height. EasyDiagnost Eleva supports a range of applications including gastrointestinal, vascular, and interventional procedures in pediatric and general imaging, as well as in women's healthcare.

Canon won clearance for its CXDI-40C detector, an amorphous silicon-based flat panel. The detector is the same size (550 x 550 x 68 mm) as the CXDI-40G (SCAN 1/8/03), a flat panel sold by Canon as an upgrade for installed film-based radiography systems. The difference is in the scintillator. The just-cleared CXDI-40C uses cesium iodide, while its predecessor uses gadolinium oxysulfide. The cesium iodide coating allows the CXDI-40C to deliver diagnostic images with approximately half the x-ray dose required by its predecessor. The newest detector also sports approximately double the detective quantum efficiency. It can be fitted into an upright stand, a table, or a universal stand.

Medison received clearance for a PACS called SonoView Pro. The Internet-based software can be deployed over conventional TCP/IP networks and utilizes Intel Pentium-based computing platforms using Microsoft Windows 2000/XP. Although compatible with all digital modalities, advanced processing functions are oriented toward ultrasound. The system supports freehand ultrasound scanning and acquires ultrasound data in real-time. SonoView displays cut planes of 3D images along short and long axes and creates images using any of several 3D rendering modes, including MIP, translucent, surface, slicing, and 3D cine.