Continuing boom in FDA clearances puts 2004 on pace for record year

August 18, 2004

June put the industry on a record-setting pace for devices cleared by the FDA this year. The watchdog agency cleared 38 radiological technologies, up from 26 in May and two ahead of the red-hot April tally.In the first six months of the year, 159

June put the industry on a record-setting pace for devices cleared by the FDA this year. The watchdog agency cleared 38 radiological technologies, up from 26 in May and two ahead of the red-hot April tally.

In the first six months of the year, 159 products passed radiological review at the agency. This is 13 more than had cleared the FDA at the halfway point last year. During 2003, the industry moved 336 products through review, more than any other year since SCAN began keeping count in 2000.

Image management technologies narrowly edged out other categories with nine clearances in June followed by seven in ultrasound, six in radiation therapy, and five each in x-ray and nuclear medicine. CT and MR each had three.

Among the nuclear medicine clearances was CTI PET Systems' ECAT HRRT, a PET scanner composed of flat-panel detector heads fashioned from LSO (lutetium oxyorthosilicate)/LYSO (lutetium yttrium oxyorthosilicate) crystals. The scanner consists of eight detector panels arranged in an octagonal pattern encircling the patient. Also covered under the 510(k) is a patient handling system, which the company plans to offer as an optional accessory.

NeuroQ PET DP Program from Syntermed assists with regional assessment of human brain FDG-PET scans and can be used to compare activity in brain regions of individual scans relative to values indicating normal activity.

Vanderbilt University is cleared to proceed with a software product that calculates radiopharmaceutical radiation doses to different organs of the body. The program, called OLINDA (organ level internal dose assessment), offers a choice of body models that represent women at different stages of pregnancy, other adults, and children, and a number of individual organ systems. Parameters describe the bio-kinetics of the radiopharmaceutical within different organs of the body. The software runs on Windows 2000 and XP Professional.

In CT, FDA reviewers passed GE's Volume Viewer Plus, which runs on the company's Advantage Workstation and Centricity PACS, as well as operator consoles of LightSpeed and HiSpeed CTs. It supports the processing, review, and analysis of CT, MR, x-ray angio, and PET images. Multiplanar reformats are achieved in any plane. Three-D views are obtained in any rendering mode, including maximum- intensity projection, volume rendering, and fly-through. Processed images are correlated to originally acquired images.

Processing capabilities include enhanced segmentation tools, such as AutoSelect and Multi-Object Volume Rendering. Enhanced visualization tools include Fused Display, Dynamic Volume Review, and ROI Tool. Real-time interactive exporting tools include Batch Reformat/Filming and Movie Builder.

China-based Neusoft Digital Medical Systems received clearance for its CT-C3000 Dual and CT-C2800 Dual families of dual-slice CT scanners. System software is an interactive program used for scan control, image reconstruction, and image archive/evaluation.

R2's ImageChecker CT Software Package with Filling Defect Indicator (FDI) passed FDA review. FDI is a thoracic image visualization and analysis tool that extends the functionality of the ImageChecker CT Workstation using segmentation techniques. FDI automatically segments locations in the vasculature of the chest containing low densities that typically correlate with filling defects.

Among the image management products reviewed in June were the STARPACS Orthopedics System from Infinitt and iPACS ORTHO from RealTimeImage. Each has the same objectives-to process and display PACS images for orthopedic surgeons doing preoperative planning and postoperative follow-up. Both devices overlay prosthesis templates on radiologic images and provide tools for repositioning the templates, as well as making measurements. They display images from different modalities and provide interfaces to image storage and printing devices.

Standouts among new MR products were enhancements to GE's Signa Infinity 1.5T and 3T featuring an Excite data subsystem outfitted with 16 independent receive channels and allowing future expansion in 16-channel increments.

MRA-CMS from Medis Medical Imaging processes MR angiography data to assist in the clinical assessment of global and regional cardiac function, as well as heart anatomy. The software measures lumen lengths, as well as minimum and maximum cross-sectional diameters. It also calculates degree of stenosis.

Siemens is preparing to market the AXIOM Artis U (SCAN 7/30/04). The angiography system supports cardiac, neuro, and general angiography, as well as radiographic/fluoroscopic procedures such as gastrointestinal and skeletal imaging.

Among the ultrasound products to clear the FDA in June were the Hudson 8000 and 9000, which visualize cavernous and noncavernous wounds. The systems use linear array transducers with frequencies ranging from 5 to 110 Mhz. Wounds assessed using the products include pressure ulcers that may invade and penetrate tissues as deep as 6 cm.

Sonoscope is cleared to begin marketing its Model SSI-600 and SSI-800, two gray-scale linear and convex ultrasound systems that support heart, abdominal, and fetal visualization. The main unit of each is portable and can be combined with video monitors, as well as special photographic units.