FDA clearances surge at year’s end to push industry to new four-year mark

The industry ended the calendar year with a flurry of FDA clearances, easily topping last year's total and establishing a new high for the decade.

In 2004, the radiology industry obtained 349 FDA clearances, 13 more than the previous year and far more than the 317 in 2000, 293 in 2001, and 295 in 2002.

Successfully completed reviews boomed in November to 42 from 36 the month before. The number dropped a bit as the year came to a close, with just 24 passing the FDA in December.

Image management accounted for much of the last two months' production, tallying 20 devices. Ultrasound took second with 14, followed by 10 for x-ray, six for MR, five for nuclear medicine, and four for CT. Radiotherapy had six. One, a device for breast self examination, was also cleared and put in the radiology category.

As impressive as the year's total number was the quality of the equipment that received 510(k)s during November and December, in some cases for the sophistication of the technology, in others for what the technology signified.

In the latter category was the clearance Dec. 23 of GE's Infinia LightSpeed. Earlier in the year, Philips and Siemens had released multislice versions of SPECT/CT. At the RSNA meeting, GE showed only iterative improvements to its Infinia Hawkeye, which is based on a nondiagnostic CT used primarily for attenuation correction. All the enhancements at that time were on the gamma camera side.

GE executives maintained at the RSNA meeting that making a multislice CT would be relatively easy, given the company's portfolio of such scanners. FDA records support their contention.

The Infinia LightSpeed system combines the Infinia gamma camera and an apparently advanced version of the company's multislice LightSpeed. References in the FDA documents relate to the 16-slice version of the CT cleared March 10, 2003.

Like the Infinia Hawkeye, the CT portion of the LightSpeed will be used to correct for nonuniform attenuation of the gamma images. It will do so, however, with far greater speed, while providing diagnostic CT information as well as anatomic localization. Infinia LightSpeed will not, however, be released as a commercial product any time soon (see accompanying article, this issue.)

Also in the hybrid category was Philips' Gemini GXL. Newly cleared configurations of the PET/CT system include six-, 10-, and 16-slice CTs. Compared with previously reviewed Philips devices, this PET/CT has a larger bore PET, the Cs-137 transmission source is removed, certain performance PET specifications are modified, and reconstruction enhancements are incorporated.

Acrorad of Okinawa, Japan, received clearance for two minigamma cameras, the MGC500-101U and MGC500-301U. The systems, which use detectors made of cadmium telluride, are smaller, lighter, and more portable than most existing gamma cameras, according to the company, making them particularly suited to intraoperative procedures.

In CT, GE Healthcare scored with its Advanced Lung Analysis software. The postprocessing analysis package is designed to assist radiologists and other clinicians in the evaluation and assessment of nodules and other lesions in the lung, helping to differentiate tissue during the radiologist's primary read. The software assesses and measures the volume of all lung nodule types, mapping their changes over time. Following a CT scan, the user clicks on a specific nodule and the software automatically calculates and displays a 3D volume, rendering the nodule as well as the associated

measurements. The software is compatible with GE's Advantage Workstation 4.2 and higher, as well as GE PACS.

Toshiba cleared an image analysis package for its Aquilion CT family. The software facilitates faster and easier visualization of cardiovascular lumens, vessel walls, plaques, and other bodies. Called PlaqueView, the package reformats vessels into curved planar and cross-sectional views, as well as maximum intensity projections. Colors are assigned to tissues based on density ranges.

Siemens received the go-ahead to market a respiratory gating option for its Sensation and Emotion CT families. The new technology improves image quality by removing the artifacts caused by respiratory motion. The company also received clearance for its CARE Contrast CT, which will be marketed as an option on the Emotion and Sensation scanners. It is designed to facilitate contrast-enhanced CT examinations by interfacing the CT and injector. CARE Contrast CT is activated at the press of a button at either the CT scanner or the injector.

In image management, Israeli firm OrthoCrat obtained clearance for its TraumaCAD, a software application designed to serve as a preoperative planning tool for orthopedic surgery. The application runs on either a workstation or PC, importing medical images and overlaying them onto templates of prostheses. The software also performs measurements that facilitate surgical planning. Using TraumaCAD, the surgical plan resides on the hospital network and can be sent to the operating room prior to surgery.

Mirada Solutions, a subsidiary of CTI Molecular Imaging, received clearance for its Scenium display and analysis software, which renders multimodality data, assisting particularly in the assessment and quantification of pathologies visualized using PET. The software is deployed via medical imaging workstations and is organized as a series of workflows that are specific to certain drug and disease combinations. It is optimized for the assessment of human brain scans, enabling automated analysis through quantification of mean pixel values located within standard regions of interest. This allows comparison of current and past scans derived from FDG-PET studies.

Two 3T head coils were noteworthy. Both will be marketed by Siemens. The 13C/1H occipital head coil is designed for the company's dedicated head scanner, Allegra. It is a transmit/receive surface coil tuned for double resonant imaging of carbon-13 and proton frequencies. Its main application will be C-13 spectroscopy, potentially including proton decoupling.

The other head coil, also designed for the Allegra, is tuned to phosphorus-31 and proton frequencies. The coil is intended for P-31 spectroscopy and, like its carbon-oriented cousin, will potentially allow proton decoupling.

GE won the right to extend its Excite data pipeline to the 0.2T Signa Profile/i MR system. The low-field scanner will also feature improved gradients with a maximum slew rate of 46 T/m/sec, compared with the previously approved gradients of 34 T/m/s.

X-ray highlights include Planmed's film-based mammography system, the Sophie Nuance Classic. Changes from the preceding Sophie and Sophie Classic models include a lower shelf constructed to allow easier assembly and better serviceability, a new Flex automatic exposure control system, more modern overall design, and enhanced user friendliness. The modification will serve as the platform for the company's full-field digital imaging efforts.

In ultrasound, Siemens obtained clearance for a general-purpose scanner dubbed Orchid. The software-controlled system acquires primary and secondary harmonic ultrasound echo data, displaying the data in B- and M-modes, pulsed- and continuous wave and color and amplitude Doppler modes, and 3D.