FDA clearances set record as 2003 drew to a close

January 28, 2004

Flood of new systems complement RSNA exhibitsMany of the products cleared by the FDA in the final weeks of last year appeared in vendors' booths at the RSNA meeting. Among them were megaslice CT scanners from Siemens and Philips, a

Flood of new systems complement RSNA exhibits

Many of the products cleared by the FDA in the final weeks of last year appeared in vendors' booths at the RSNA meeting. Among them were megaslice CT scanners from Siemens and Philips, a premium performance PET/CT device from CTI Molecular Imaging and Siemens, a new computed radiography system from Fuji, and a digital fluoro and enhanced MR systems from GE. But many more coasted in under the radar-upgrades and new products that, together with the technology showcased in Chicago, accounted for 101 FDA clearances from October through the end of December. The year-end surge boosted the annual total to a whopping 336 clearances, the most since DI SCAN began tracking these clearances in 2000 and 19 above the previous high recorded for 2000.

Image management had the most clearances with 18, edging out x-ray by one. Ultrasound and RT each had 16. MR had 14, although seven of these were coils. CT had 11 and nuc med had nine.

Analogic won clearance for two digital x-ray systems. The AN5150 is dedicated to chest radiography. The AN7150 is a general radiography system designed for studies of the body including skull, spinal column, chest, abdomen, and extremities. Mammography is excluded. Exposures are taken with the patient sitting, standing, or lying either prone or supine. Images obtained with either system are previewed on the operator workstation seconds after exposure. Accepted images are stored or exported to a PACS.

A compact, mobile mini-C-arm cleared the FDA for fluoroscopic imaging of patient extremities. The XiScan 4000, by XiTec Holdings, operates in manual or automatic exposure rate control modes with options for reduced radiation (low dose) and high resolution (standard dose). It features touchscreen controls to manage onscreen patient information and image storage.

Siemens was cleared to market a sliding gantry option for CTs. The subsystem allows whole-body CT on different types of patient tables in different environments. The sliding gantry option integrates horizontal movement, which is usually the function of a dedicated CT table, into the CT gantry itself. To facilitate this, the CT gantry is mounted on a rail system. With this device, cross-sectional images can be acquired from either the same axial plane taken at different angles or from spiral planes at different angles. The spiral planes would be achieved through the continuous rotation of detectors and the x-ray tube and the simultaneous movement of the sliding gantry.

The way is also clear for Siemens to begin marketing CT software that provides an extended field-of-view. This software supports the selection and image reconstruction of variable targets. Maximum visualization is a 70-cm volume, which is achieved through the extrapolation of reconstructed data and convolution with a fast Fourier transformation. The company can also commercialize LungCare CT, a self-contained image analysis software package for evaluating CT volume data sets. The package combines enhanced digital imaging processing tools, including maximum intensity projection and multiplanar reconstruction, with evaluation and reporting tools. It is designed to confirm physician-identified lung lesions and to evaluate, document, and follow up lesions using standard or low-dose spiral CT. Visualization tools allow volumetric analysis of lesions over time, helping to assess the efficacy of treatment.

GE's new Advantage 4D is a noninvasive software/hardware option that processes and displays CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software groups images by selected phases, allowing the user to retrospectively define the respiratory phase best suited to improve image quality. The option is suited for targeting and verifying volumes to be treated as part of radiation therapy.

Medicsight was cleared to market its MedicColon, software that assists in the evaluation of polyps, cancers, and other lesions in the colon as detected with CT. The virtual colonography system allows the user to select regions of interest (ROI) either manually or by choosing a single or double seed point followed by semiautomatic detection of the ROI boundaries. Polyps and other lesions are visualized in 2D and 3D and measured for size and volume.

A software package from Viatronix, called V3D Vascular, automates the routine inspection of blood vessels detecting stenosis, plaque, bulge, aneurysmal sac, and dissection found on CT, MR, or 3D x-ray angiography. It also supports the interactive segmentation of any vessel by hiding certain parts of the data set from display for critical evaluation of selected parts.

Chinese manufacturer Neusoft received marketing clearance for its Superopen 0.23T MR system. The new product joins the Superopen 0.35T, which was previously cleared. Both are open-style, permanent magnet MR scanners.

GE featured the migration of Excite at the RSNA meeting from 1.5T to 3T and 0.7T scanners, but the company obtained FDA clearance to equip its 0.35T Ovation with the data pipeline as well. GE is also cleared to sell its 0.2T Signa Profile/i system with an increased gradient slew rate of 42 and optional high-signal-to-noise head coil.

GE cleared three ultrasound scanners: the Logiq5 Pro/Expert, GE Logiq Book BT03, and GE Marlin. The Expert is a full-featured version of the currently existing general-purpose Logiq5 platform; Pro is a reduced-feature configuration. Both consist of a mobile console that acquires, processes, and displays digital information. The user interface includes a computer keyboard, specialized controls, color video CRT display, and LCD touchscreen. Logiq Book BT03 is an enhanced version of its compact predecessor, featuring additional transducers that extend its clinical applications. GE Marlin is a full-featured echocardiography system in a compact, portable package. It includes interchangeable electronic array transducers that extend its capability to general imaging. It has the same intended use and overall imaging capability as the company's Vivid 3.

FDA reviewers cleared QDR Explorer, the bone densitometry system Hologic showed in October at the annual meeting of the Journees Francaises de Radiologie. The system rounds out the value end of the company's fanbeam bone densitometers.

The company also obtained clearance for its DR ImagePro, a Windows-based software package that provides basic and advanced PACS functions. The software can merge two to five DICOM image files of an individual patient to aid visualization of large areas of interest. The software merges or stitches the separate images together manually, allowing users to draw lines and angles within the images to obtain measurements.