FDA reviewers clear 22 devices in April for U.S. imaging market

May 31, 2005

The imaging community continued to drift in April on a flat sea of FDA clearances, as just 22 devices, one more than in March, managed to pass the agency’s review.

The imaging community continued to drift in April on a flat sea of FDA clearances, as just 22 devices, one more than in March, managed to pass the agency's review.

Eight of these were in image management and another six in x-ray. MR accounted for three clearances, although two were coils and the third an upgrade. Radiotherapy had two. Ultrasound, nuclear medicine, and CT each had one.

X-ray was the runaway winner in substance. Philips Medical Solutions received clearance for a new family of image detection components. The FLXIS family is composed of image intensifiers, a camera, image processing functionality, and a remote control user interface. These components can be set up in various ways, with each configuration paired with a display module.

The Centrion 500 C-Arm System, developed by Osteosys of Brookeville, MD, is a compact digital C-arm fluoroscopic system. It offers real-time pulsed fluoroscopy, which promises to reduce dose by up to 85%, according to the company. It is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures.

The Revolution XR/d from GE Healthcare offers image pasting and autopositioning. Image pasting allows the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end-user workflow by minimizing the number of steps needed to set up and initiate imaging.

Agfa is now clear to market its CR50.0, a computed radiography system featuring enhanced photo-stimulable storage phosphors. Compared with its predecessor, the CR25.0, this new product offers improved scan time, according to the company. It was shown at the RSNA meeting last year.

Agfa also had a notable clearance in image management. Software that is part of the company's Impax OT3000 enables planning of orthopedic surgeries. Along with basic diagnostic display station functionality, the software matches diagnostic images with a database of orthopedic implant geometries and dimensions.

Shimadzu is set to market a new mobile diagnostic ultrasound system. The Echoview/Shimsonic supports flat linear array, convex linear array, and sector probes with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, pulsed Doppler, and color mode.

In nuclear medicine, Israel-based UltraSPECT gained clearance to sell in the U.S. its Xact.cardiac and Xpress.cardiac image processing systems, which interface with gamma cameras. The two software packages are capable of acquiring, formatting, or storing scintigraphy data in traditional formats. They also work with 3D and various animated sequences, showing kinetic attributes of the imaged organs.

Among the other notables in April's FDA clearance basket was Syngo Body Perfusion-CT, a postprocessing software package designed to evaluate perfusion of organs and tumors. The package runs on an Intel-based PC platform designed to postprocess images acquired using Siemens CT scanners. Syngo Body Perfusion-CT software calculates blood flow, blood volume, and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. It allows the separate calculation of the arterial and portal venous component of hepatic perfusion and supports evaluation of regions of interest and the visual inspection of time-density curves. A potential application is the characterization of tumors by analyzing the differences between their perfusion parameters and those of normal tissue. Determination of changes in perfusion parameters during the course of treatment may be helpful in therapy monitoring.