February FDA clearances slacken in number and significance

April 2, 2006

Vendors are off to a slow start this year in terms of FDA clearances, managing just 17 in February for a total of 38 for 2006. Only once in the last six years has the industry done worse: In 2004, FDA reviewers cleared just 35 devices in the first two months of the year.

Vendors are off to a slow start this year in terms of FDA clearances, managing just 17 in February for a total of 38 for 2006. Only once in the last six years has the industry done worse: In 2004, FDA reviewers cleared just 35 devices in the first two months of the year.

The significance of most devices was similarly disappointing. A listing of February clearances posted in mid-March on the FDA Web site included five dental products. Four image management devices also cleared the FDA in February, as did three radiotherapy products: two brachytherapy devices and a multileaf collimator. Nuclear medicine and x-ray each had one clearance.

GE Healthcare cleared two devices, its Innova 3131(IQ) and 2121(IQ), under a single submission. The two vascular systems are about the same as their predecessors, the Innova 3100 and 2100, except that they are equipped with two rather than one detector to allow biplane fluoroscopy. The company also migrated features from its Advantx LCN+ biplane positioning system into each of the new devices. The 3131(IQ) and 2121(IQ) can each be configured with software to reconstruct 3D volumes from rotational fluoroscopy acquisition to assist in diagnosis, surgical planning, interventional procedures, and treatment follow-up. The software option InnovaSpin permits fast-spin rotational angiography.

The sole CT clearance was for the Hitachi CXR16, a 16-slice CT scanner equipped with a 7.5-MHU x-ray tube and a 72-kW generator. The system is designed to postprocess up to 40 images per second.

Merge, through its Cedara Software unit, won clearance for its Cedara I-Response and Cedara PET/CT software. The products, extensions of the company's Cedara I-SoftView, are designed to coregister MR, PET, SPECT, and CT data sets. They can also segment regions of interest and calculate, display, and report relative difference in data values found in these ROIs.

Siemens biograph 6 is virtually the same as the preceding model of the same name, composed of a six-slice CT and high-performance PET scanner. The major difference is a modification of the detector's mechanical configuration.

DART-12 from Direx Systems is a Linac-based micromultileaf collimator (MMLC) that shapes the radiotherapy beam to fit the geometric contours of the target cancer. The device includes the MMLC module, the Linac interface, and a workstation with control software.