FDA clearances boom for second straight month

November 7, 2005

The radiology industry appears to have bounced back from a bruising first half-year, during which the number of radiological devices cleared lagged far behind the pace set in the last two years. Thirty-three such devices passed FDA muster in September, just shy of the year’s highwater mark of 35 set in August.

The radiology industry appears to have bounced back from a bruising first half-year, during which the number of radiological devices cleared lagged far behind the pace set in the last two years. Thirty-three such devices passed FDA muster in September, just shy of the year's highwater mark of 35 set in August.

The back-to-back regulatory surges have put the industry on track for a third consecutive year of more than 300 clearances and in the running for a new record. OEMs have scored 232 clearances as of September, just 15 behind last year's pace, which finished with a five-year high of 349.

The devices were as impressive as the numbers with several showing the makings of major products. Siemens' Project P45, identified in the FDA filing as the Somatom Definition, is a whole-body CT scanner featuring two continuously rotating tube-detector systems. Hitachi Medical Systems of America's HHFI is a superconducting, open-gantry 1.5 T MR scanner. (Its design is based on Hitachi's Altaire Open MR product, according to the filing.)

In sheer numbers, image management dominated with 13 of the September clearances. Other categories trailed far behind: MR with five, ultrasound and radiotherapy with four each, CT and x-ray with three each, and nuclear medicine with one, a quadslice combination SPECT/CT from GE Healthcare.

This device, the Hawkeye 4 option for dual-head variable-angle gamma camera, is a modification of the first hybrid SPECT/CT, the Hawkeye option cleared in 1999. The option cleared in September is a step up, incorporating a quadslice rather than single-slice CT. Each rotation generates four 5-mm slices with an axial coverage of 20 mm. The CT is integrated with the Infinia gamma camera, using the same acquisition station, patient table, and slip-ring gantry as the currently marketed version.

A pure-play CT submission from Analogic involves three systems: SyneRad Impact 60, SyneRad Impact 72, and Analogic AMS 1600. All three are 16-slice scanners with a 0.5-sec minimum rotation time. They all have a gantry aperture of 70 cm and use the same control console, operating system, and software.

Operator consoles include two 20-inch high-resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity.

The AMS 1600 is the platform on which the two SyneRad systems are built. It is identical in construction (except for cosmetic differences in the covers) to the SyneRad Impact 72. The difference between the SyneRad systems is the high-voltage power supply mounted on the gantry. The Impact 60 generates 60 kW, while the SyneRad Impact 72 generates 72 kW. The kVp levels are the same for both. The upper mA setting for the 60-kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA.

In the radiotherapy category, BrainLAB's iPlan RT FiberTracking prepares and presents patient and image data based on MR diffusion-weighted imaging for use during stereotactic radiation treatment planning. The diffusion images are used to calculate and display fiber bundles in a selected region of interest.

In MR, Philips' Achieva, Intera, and Panorama 1.0T can now be outfitted with Release 2, which introduces several new functions. Fiber Tracking employs diffusion tensor imaging to extend the functionality of diffusion-weighted imaging for measuring the directional dependence of the diffusion coefficient in tissue. This improves visualization of white matter structure in the brain. Smart Scan enables automatic planning of geometries and acquisition. ExamCard fully automates data acquisition. Regional Perfusion Imaging with Arterial Spin Labeling provides a noninvasive acquisition method for selectively mapping flow territories and determining regional perfusion in the human brain. Kt-BLAST (Broad-use Linear Acquisition Speed-up Technique) reduces the scan time of dynamic and multiphase studies by using k-space data from other dynamics/phases. Kt-SENSE combines kt-BLAST with SENSE parallel imaging. Kt-BLAST and kt-SENSE can be applied to reduce scan time or improve temporal resolution of dynamic or multiphase studies.

Siemens' MRI Soft Tissue Motion Correction Software VA 10A supports the registration of one or more volumes relative to an initially supplied reference volume, reducing image deformation and displacement in soft-tissue shape and location that may occur due to patient motion between acquisitions of serial MR images.

GE has clearance to market 32-channel versions of its 1.5T and 3T Signa HD MR scanners. The architecture allows future expansion in 16-channel increments.