FDA clearances dip in April, but show industry strength

May 24, 2006

FDA clearances dipped in April compared with their spike in March, but the latest month put the industry back on track with previous years’ performance, outshining five of the past six Aprils with 28. That brings the total to 80 clearances this year -- in the ballpark with, though still lagging behind, industry performance since 2000.

FDA clearances dipped in April compared with their spike in March, but the latest month put the industry back on track with previous years' performance, outshining five of the past six Aprils with 28. That brings the total to 80 clearances this year - in the ballpark with, though still lagging behind, industry performance since 2000.

Most clearances derived from radiation therapy, which boasted nine. Ultrasound celebrated six. Image management had five. X-ray claimed four. MR and CT each had two clearances.

Among image management systems was the Siemens syngo US Workplace, which is optimized for handling images acquired by ultrasound systems using standardized formatting. Images are transferred from the ultrasound system to the PC hosting the syngo software by CD-ROM, DVD, or a network connection.

Traxtal Technologies leveraged image processing techniques to develop a real-time 3D visualization system for preoperative planning and intraoperative navigation. The system, called Abaris, displays the simulated image of a tracked insertion tool, such as a biopsy needle, guidewire, or probe, on a computer monitor. The screen displays images of the target organs and the current and projected path of the interventional instrument, taking into account patient movement. It transforms 2D images from a digital modality, such as CT, MR, PET, SPECT, or x-ray fluoroscopy, into dynamic representations of the target area, correlating scan sets with each other and with the patient. The system is designed to facilitate minimally invasive surgical procedures.

In ultrasound, the iView from Korean vendor OnDemandSoft reconstructs 2D fetal features recorded with ultrasound in three dimensions. It is designed as an add-on to existing ultrasound systems.

The two MR clearances in April included the Vanguard Breast MRI Auxiliary Table with eight-channel coil array. The tabletop, developed by Sentinelle Medical, is compatible with GE Signa 1.5T scanners, namely the 3X-LX, Echo Speed, and TwinSpeed. It supports the patient, imaging coils, and a mechanism for modest compression and immobilization of the breast, as well as a means for guiding an interventional device.

An aperture in the table base maximizes physician access to the breasts when the tabletop is in the home position. This is useful for guiding interventional devices, such as biopsy needles. When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile single-use disposable fenestrated plate.

In x-ray based imaging, Philips received clearance for its XperCT, a software option for the Allura Xper family of angiography products. XperCT is intended for imaging bone, soft tissue, and other body structures, then reconstructing 3D volumes from rotational fluoroscopy acquisitions. The resulting CT-like images are meant to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

In CT, GE won clearance for a second-generation CT vessel analysis postprocessing software package. The software, which runs on GE's Advantage Workstation (AW) platform, CT scanners, and PACS reading stations, is intended for the analysis of 3D CT angiographic images, delivering data to support stenosis analysis and pre- and post-stent procedures, as well as directional vessel tortuosity visualization.

The FDA also cleared GE's LightSpeed Xtra. The device delivers CT images to guide minimally invasive procedures, such as biopsy and ablation of tumors and pathology, in obese patients. The 80 cm bore is available as part of GE's LightSpeed RT Pro 16, which is optimized to assist planning of radiation therapy procedures. As part of the LightSpeed Xtra, it accommodates large patients to allow easy access during interventional procedures. The gantry onboard the 16-slice system can rotate up to 0.5 seconds per rotation, delivering a maximum total coverage of 20 mm in the axial direction.