FDA clearances slow down from summer’s red-hot pace

October 13, 2004

The flow of newly marketable devices cooled a bit in August, as FDA reviewers cleared 27 products for U.S. sale, down from the 36 that passed in July. In past years, the number of devices clearing the agency has trended higher toward the end of the year, as manufacturers made their final push to ready equipment for launch at the RSNA meeting. This year the extraordinary activity seen during summer may have set the stage for a change.

The flow of newly marketable devices cooled a bit in August, as FDA reviewers cleared 27 products for U.S. sale, down from the 36 that passed in July. In past years, the number of devices clearing the agency has trended higher toward the end of the year, as manufacturers made their final push to ready equipment for launch at the RSNA meeting. This year the extraordinary activity seen during summer may have set the stage for a change.

The number of clearances in August was dead even with August in each of the preceding two years, but slightly behind both 2000 and 2001. Similarly lagging was the sophistication of many of the devices.

All of the four MR devices cleared in August were coils. The only nuclear medicine device to pass muster was a remanufactured system based on decades-old detector technology. CT could not match even that, as the category failed to record a single entry. One device - a reference database for use in bone densitometry - fell outside the usual classification criteria.

Two of the eight x-ray-based systems were for dental applications. This category, however, was marked by several noteworthy products. The OEC Olympus Mobile Fluoroscopy System from GE Healthcare provides fluoroscopic and spot-film images of a patient during diagnostic, surgical, and interventional procedures. The system can be used to perform cholangiography and endoscopy, as well as procedures in urology, orthopedics, neurology, and cardiology. Vascular, critical-care, and emergency room procedures are also supported.

Running counter to a trend that has seen increasing use of flat-panel detectors, the OEC Olympus depends on an image intensifier. The mobile C-arm performs linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances from the patient.

A variation of this product, which also cleared the FDA in August, has an integrated navigation system designed to assist the surgeon in locating anatomical structures during open or percutaneous procedures. The integrated surgical navigation system reconstructs 2D images in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's anatomy, based on preoperative medical images. The system is especially suited for use during stereotactic surgery, as its fluoroscopic images can be used to easily visualize ridged anatomical structures such as a sinus, cranial area, long bone, or vertebra.

GE also gained marketing clearance for a bolus-chasing sequence. The sequence is designed for use on the company's flat-panel digital fluoro systems, Innova 4100 and Innova 3100, to support subtraction angiography of the lower limbs.

Of the four image management devices, two were multimodality workstations. The PC-driven Dominator Reading Station from DR Systems includes a color flat-panel monitor and two or more high-resolution monitors. The Hologic SecurView DX can handle any digital data set but is particularly suited for the review of digital mammograms. It includes two high-resolution gray-scale monitors (FDA-cleared for mammography). Image processing is done externally from the SecurView DX. It will complement Hologic's Lorad Selenia full-field digital mammography system and has been cleared by the FDA as an adjunct to any FDA-approved FFDM system (SCAN 9/1/04).

In this category, the FDA also cleared a high-resolution flat-panel monitor for digital mammography (SCAN 9/15/04) and a software package for reconstructing nuclear medicine images. The SeeMor 5.0 product from Areeda Associates is designed for transferring and viewing diagnostic images. Standard features include clipping, window/level adjustment, magnification, pan, cine, orthogonal view reconstruction, cascade, and tile. The ReconTool processing application within SeeMor 5.0 can be used to reorient and tomographically reconstruct myocardial perfusion data sets acquired with SPECT and PET.

Of the four devices in radiotherapy, Varian's upgrade of its OnBoard Imager stood out. The device has been modified to correct patient positioning for radiotherapy based on a comparison of fiducial markers in digital images to fiducial markers in a reference 3D volumetric data set.

Five ultrasound devices were cleared in August. Siemens Medical Solutions upgraded its Acuson Cypress from an echocardiography configuration to a multipurpose platform. The lightweight, portable unit can now be used for general imaging and cardiology. It also specifically supports intraluminal and intracardiac applications, as well as peripheral vascular imaging.

A German firm, DWL Elektronische Systeme, gained clearance to market an ultrasound system designed specifically for assessing the blood vessels that supply hemorrhoids. An 8-MHz pencil probe is used to measure blood flow velocities in the subcutaneous arteries and veins. The product, called Hemo-Dop, promises to be useful when doing sclerotherapy and Barron ligature.