Radiological device vendors reached a record high for midyear clearances by the FDA in June, scoring 34 premarket notifications, raising this year's tally to 168. The industry has come close to this midyear high only once since DI SCAN began tracking FDA clearances in 2004, when 159 devices were favorably reviewed.
Eleven of the 34 clearances in June 2006 involved image management. Eight addressed ultrasound. X-ray came in third with seven clearances, followed by radiation therapy with five nods from the FDA. There were two clearances for MR and one for CT.
In image management, the FDA cleared Siemens Molecular Imaging's Scenium 1.1 display and analysis software, which enables processing, quantification, and display of PET and SPECT scans. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest to allow the comparison of PET and SPECT studies. It will be deployed via workstations and organized as a series of workflows to use with particular drug and disease combinations.
A second Siemens' clearance, syngo TrueD, allows viewing, manipulation, 3D visualization, and comparison of medical images from multiple modalities or images taken with a single modality but at different times. The application supports analysis of functional data, such as those derived from PET or SPECT, as well as anatomical data sets, such as those coming from CT or MR. The images can be viewed in multiple formats including maximum-intensity projection and volume rendering.
Kyron Clinical Imaging is cleared to market its BrainAcquireRx/BrainProcessRx data suite. The MR software will be used to acquire and process blood oxygen level dependent (BOLD) functional MR data sets. The BrainAcquireRx software application presents a scripted series of synchronized visual and auditory stimuli and cognitive/motor tasks to the patient being scanned. Patient responses and image data from the MR scanner are stored for use by the BrainProcessRx application, which postprocesses the data for quality control and subsequent viewing of fMRI studies. These applications can also be used to assist in scripted data acquisition and postprocessing of anatomical, functional, and physiologic MR imagery, including MR spectroscopy and MR diffusion.
FujiFilm Medical Systems USA can begin marketing its Obliquus, an integrated MIP and multiplanar reformatting software package intended for use with Fuji Synapse Workstation Software Version 3.1.1 and higher. Available memory dictates how many slices can be visualized, but 1 gigabyte memory capacity allows about 600 slices of CT images to be processed, according to the company's FDA filing.
Vital Images has received clearance on Version 3.9 of its Vitrea2, which includes the SUREPlaque tool kit. This application, intended for use with Toshiba's Aquilion CT scanners, helps stratify patients identified as having coronary artery disease.
GE Healthcare's AutoBone 2 is an optional software extension of the company's Volume Viewer, which runs on the Advantage Workstation. It facilitates visualization of vasculature and assists in segmentation of bony structures and calcifications from abdominal and extremity CT angiography data.
GE's FullCard Analysis is a PET/CT postprocessing analysis package that allows automated processing, visualization, and quantification of parameters of myocardial perfusion and function. Parameters include perfusion, end-diastolic and end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation.
Included among ultrasound devices cleared in June was a mobile version of Toshiba's Nemio system, the Nemio XG.
In specialty ultrasound, GE received clearance to market an intravascular option for its Innova series of x-ray angiographic systems. The option provides enhanced connectivity with Volcano's IVUS products by automatically synchronizing patient demographics, providing remote access to commonly used IVUS functions from the Innova tableside user interface, and displaying IVUS images on the multimonitor display of the Innova cath lab system.
Complementing this clearance, the FDA also cleared Volcano's Angio-IVUS mapping system, which is designed to provide a common frame of reference for IVUS and angiography of the coronary vessels. The system indicates the location of the IVUS cross-sectional imaging plane as it relates to 2D and 3D angiographic images. The mapping system works on the In-Vision Gold imaging console, which is designed to process traditional x-ray angiographic images.
In x-ray, Alara received clearance for its CRystalView R200, a desktop computed radiography system based on photostimulable phosphor plates. It consists of a CR reader and a workstation with software, cassettes, and imaging plates. CRystalView R200 outputs images and patient information to a PACS using standard DICOM 3.0 protocol.
The FDA also cleared Ziehm's Vision R C-arm, which provides pulsed and continuous fluoroscopic imaging, as well as spot imaging of the patient during diagnostic, interventional, and surgical procedures. The Ziehm Vision R has two mobile units: a mobile C-arm stand and a monitor cart/workstation. The system performs rotational and linear movements that allow imaging components to be positioned at various angles and distances from the patient.