Pace of FDA clearances quickensas major devices pass in July

September 15, 2004

This year is proving exceptional in terms of imaging technology development. After a record number of FDA clearances were granted in June, another 36 devices were cleared in July.

This year is proving exceptional in terms of imaging technology development. After a record number of FDA clearances were granted in June, another 36 devices were cleared in July.

Six more devices received 510(k) clearance in July than in the same month last year, and the total number was 19 ahead of last year's record-setting pace. Many of the devices are substantial offerings, likely to be showcased at the RSNA meeting in November.

Nine devices addressed MR and eight involved image management. Ultrasound, radiation therapy, and x-ray each accounted for five, while nuclear medicine and CT each had two devices cleared.

MR products included CAAS MRV, a software tool designed for functional analysis of the heart based on multislice, multiphase MR images (SCAN 9/1/04). But the real standout was Philips' Panorama 1.0T, a vertical-field magnet. The firm expects to have commercially viable 1T open systems operating at two U.S. clinical sites before the RSNA meeting, according to company sources (SCAN 6/2/04).

The Panorama 1.0T operates on the same platform as the company's cylindrical Intera Achieva, according to the FDA filing. The device features a superconducting actively shielded magnet with a static field of 1T and a wheeled patient table that docks with the scanner.

If released as expected, the Panorama 1.0T will have been a long time coming. Philips struggled for several years to overcome engineering and manufacturing challenges. Facing similar obstacles, Siemens Medical halted its development of an open 1T system, opting instead to build a 1.5T ultracompact, "open-bore" magnet (SCAN 7/30/04. This system, the Magnetom Espree, has the widest bore of any commercial high-field MR scanner, according to the company. It cleared the FDA on July 21.

The Espree was the second Siemens open-oriented system to pass FDA review in July. Five days before it was cleared, the agency signed off on Siemens' Magnetom C!, a clam-shaped open system built around a permanent magnet generating a 0.35T field (SCAN 8/18/04).

Another notable member of the July MR graduating class was MRI Devices' DynaCAD, a postprocessing software package that displays and analyzes dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions, thereby minimizing patient motion. It segments and labels tissue types based on enhancement characteristics (parametric image maps) and performs other user-defined postprocessing functions such as image subtractions, multiplanar reformats, and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid on the source image. DynaCAD also provides an intervention planning tool called DynaLOC, which assists MR guidance of percutaneous interventional procedures.

As usual, several MR coils were were submitted to and passed FDA review. Among them was the model BBC-127 biopsy breast coil from MRI Devices, which enables diagnostic images of the breast and chest tissues as well as MR-guided breast biopsy and lesion localization.

In ultrasound, Aloka won clearance for its ProSound Alpha 5 diagnostic ultrasound system and transducers. The new product was exhibited at the World Congress on Ultrasound in Obstetrics and Gynecology in Stockholm, Sweden. Advances in microcircuit technology allow large-scale integration of the electronics built into the digital front end of the system, contributing to image quality, according to the company.

GE received clearance to begin marketing an advanced version of its Vivid 7 echocardiography ultrasound platform. The Vivid 7 Dimension was unveiled Aug. 30, along with a highly portable echo system, the Vivid i.

In image management, Siemens is cleared to market syngo TrueD, image manipulation software intended to fuse data sets from several imaging modalities. Data fusion is performed on 3D volume data sets and may be represented in different output formats, including volume rendering. Measurements are also possible, allowing quantitative comparisons with data acquired at different times. The new software, based on the Windows XP operating system, supports DICOM-formatted images and information.

Philips' Allura Xper FD10, shown as a work-in-progress at the Heart Rhythm 2004 meeting in May (SCAN 6/2/04), can now be marketed in the U.S. The stationary angiographic system features a solid-state x-ray detector. It is intended for use in cardiovascular and vascular x-ray imaging applications, including interventional procedures such as PTCA and stent placement and atherectomies, pacemaker implantations, and electrophysiology and diagnostic procedures. The monoplane system, which can be configured as either a floor-mounted or ceiling-suspended frontal stand, is compatible with specified magnetic navigation systems.

Ortho-CMS from Medis Medical Imaging of the Netherlands facilitates the diagnosis of orthopedic digital images and allows orthopedists to perform a presurgical planning and postsurgical evaluation. Ortho-CMS can also help assess the quality of orthopedic implants and measure donor bones for joint replacements.

Agfa is cleared to release a new CR product, a compact system that the company called the CR25.0 in its submission to the FDA. The company developed the system using technology from the high-end ADC Compact Plus, reorganizing and miniaturizing electronics, which resulted in lower power requirements and a compact footprint.

Philips is set to release an upgraded version of its currently marketed Gemini 16 PET/CT system. Modifications include the addition of third-party cardiac display and analysis software and enhancements to DICOM workflow. The cardiac software quantifies cardiology images and data sets, including myocardial perfusion for the display of wall motion and left ventricular function parameters from gated myocardial perfusion studies. The software also aligns 3D coronary artery images obtained from CT coronary angiography onto the myocardium.

lmagenMD from Cardiovascular Imaging Technologies of Kansas City, MO, displays myocardial perfusion SPECT as well as PET images on laptop computers. Users can examine raw, short-axis transmission slices and gated short-axis studies for abnormalities and artifacts. Also included is an application for the display and analysis of gated short-axis blood pool SPECT data sets. The software package can be configured to quantify the extent and severity of myocardial defects.

CT products that passed FDA muster included Lung CAR (computer assisted reader), a software tool designed to assist evaluation of nodules and other lesions in the lung. The PC-based stand-alone software helps users extract the region of interest either manually, using a drawing tool, or semiautomatically by selecting single or double "seed points" followed by interactive fine-tuning of the boundaries. Quantitative tools measure lesion volume and other characteristics over time. (SCAN reported that the software cleared the FDA on Aug. 16 [SCAN 9/1/04], but agency records indicate that the decision was made July 22.)

Image Analysis of Columbia, KY, is branching out from its home turf in densitometry with a CT software calcium scoring program. N-Vivo Calcium Score quantifies calcified plaques in the coronary arteries and aorta using CT images. The software, which cleared the FDA on July 13, runs on a standard PC with basic image processing, database, and reporting functions. N-Vivo may be used to monitor progression and regression of calcium.