FDA clearances rebound to normal in February

Philips' engineering accounts for most standouts

The number of radiological devices clearing the FDA popped back into the normal range in February, as the watchdog agency awarded 23 such clearances. The number was in line with that month's four-year performance, which ranged from a high of 28 in 2000 to a low of 21 in 2003.

Two categories tied for first, as radiotherapy and x-ray each tallied five clearances. Image management had four, ultrasound and nuclear medicine each had three, MR two, and CT one.

Standouts in radiotherapy were the On-Board Imager from Varian Medical Systems and the Simulix Evolution from Nucletron. Both involve flat-panel detectors. On-Board Imager is an integrated robotic platform for image-guided cancer treatment and a critical piece of Varian's image-guided radiation therapy initiative (SCAN 3/10/04). Using an amorphous silicon flat-panel detector that records anatomic landmarks, On-Board Imager helps adjust the focus of radiation to follow shifts in tumor locations due to changes in patient positioning and motion.

Simulix Evolution features a digital option for Nucletron's Simulix HP simulator. Patients are positioned and imaged using a conventional radioscopy and fluoroscopy system with a 41 by 41-cm flat-panel detector in place of the image intensifier. Digital images are relayed to a PC-based simulator workstation.

OrthoPACS from eTrauma.com was among the February image management clearances. The product is designed to support specific orthopedic applications, allowing surgeons to view clinical images and retrieve patient data. OrthoPACS consists of acquisition and transmission, viewing station, and storage and remote imaging modules. Images are used in conjunction with templates for prosthetic devices, to support the choice of these devices when planning surgical procedures.

Cardiac analysis software and a spine coil were the two MR clearances. The Chase Cardiac Analysis System from Chase Medical of Richardson, TX, is used to derive anatomical and functional information from cardiac MR studies. The information is presented as an interactive 3D model and as text reports. The system automates the segmentation of cardiac structure and calculates anatomical and functional parameters.

The Synergy Spine Array coil from Philips works on the company's Panorama 0.6T system to enhance images of the thoracic and lumbar spine and sternum. It promises to improve patient handling and to image larger patients than can be done with the body and spine coils built into the 0.6T open scanner.

Nuclear medicine clearances were awarded for a gamma camera from IS2 Medical systems and for the upgrade of a quantitative blood pool SPECT product from Philips. The highly portable Mobile Compact Digital Cardiac Camera includes signal analysis and display equipment. AutoQuant Plus supports automated display, review, and quantification of nuclear cardiology images and other data. The Plus version includes an interactive stand-alone software application for the automatic segmentation and quantification of gated short-axis blood pool SPECT, as well as an optional automatic report generation feature.

Philips' new Ensphere Tempo is a Windows-based nuclear medicine workstation specific to the cardiology market. It offers tools for performing image review, processing of source data, postprocessing, hard-copy production, interpretation, and report generation. Utilities built into the system support workflow and data management.

Philips scored again in ultrasound with its QLAB version 3.0, which offers several plug-ins that work in combination with the company's ultrasound systems. The Cardiac 3DQ plug-in opens, displays, manipulates, and measures 3D image files. It also calculates distance, area, volume, and mass measurements in the multiplanar reconstruction images derived from 3D ultrasound data sets. The General Imaging 3D Viewer Plug-in changes 3D volume rendering parameters. The Microvascular Imaging Plug-in performs a maximum intensity projection convolution of the cine information and exports the resulting information in a standard AVI file for use in presentations.

The lone CT clearance was for Philips' CT Brain Perfusion Option. Designed to work on the newly introduced Brilliance CT family, this option demonstrates changes in image intensity over time, supporting the analysis of dynamic and serial CTs after the injection of contrast. It calculates the parameters related to brain perfusion and displays the results as a composite single image calculated from a set of time course images.

In radiography, United Radiology Systems of Deerfield, IL, received clearance to market its PXP-HF family of portable x-ray systems, which are designed for general radiographic applications in the field or clinics. The PXP-20HF and -40HF portables are intended for use as mobile systems to be transported from hospitals to nursing or private homes. The 15HF is designed for use in foot- and hand-care clinics, as well as by sports medicine groups in the clinic or at stadiums.