FDA November clearances settle into mid-twenties

Image management and x-ray devices dominate

The number of 510(k) clearances for radiological products stabilized in November, substantially below year-ago levels but in line with the months immediately past. This underperformance continues a trend present throughout the year. In the first 11 months of 2001, the FDA cleared just 265 radiological products, compared with 290 over the same period in 2000-a 9% shortfall. The downward trend accelerated in the fourth quarter as October clearances dipped from 30 in 2000 to 25 in 2001 and November clearances from 28 to 24.

Image management products and x-ray systems led November 510(k)s with five apiece. MR and ultrasound systems each had four. Radiotherapy, which had been among the leading groups during the two months prior, garnered just two clearances, as did CT and nuclear medicine.

The five image management systems included a multiformat camera, Drystar Model 4500M from Agfa (cleared Nov. 29), and a software application called eFilm Video (cleared Nov. 20) from eFilm Medical. The eFilm software captures video streams from analog devices and converts them to DICOM-compliant cine loops. An image processing system called Deep Gray from CorTechs (cleared Nov. 2) measures the volume of any brain structure visualized using MR and provides drawing tools as well as semiautomatic labeling for documentation. Two PACS were cleared. H Innovation's iConnection 3D is a software application that integrates processing and distribution of 2D and 3D images. It works in concert with the company's iConnection 3D workstation, which cleared the FDA a month earlier (SCAN 11/21/01). The second system, Marosis PACS from Marotech (cleared Nov. 8) handles images and other patient data using a high-speed network connected to scanners, workstations, and storage devices.

The five x-ray devices included a digital sensor from Agfa. The flat panel, called ADC Pediatric, cleared Nov. 14. GE's dual-energy tissue-equalization software options for digital radiographic systems cleared Nov. 2. The tissue-equalization algorithm enhances contrast in thick body areas using two images that are created using different x-ray energies. Toshiba's DFP-8000D, which cleared Nov. 15, processes, displays, and records digital angiographic images, then replays the images in support of diagnostic and interventional procedures. Sedecal USA received clearance Nov. 2 for its Optima URS, a universal radiographic system. The conventional mammography system, Giotto Image from MEDX, passed the FDA Nov. 30.

Three of the four MR clearances involved coils, and MRI Devices developed two of them: the Allegra head array coil and a neurovascular array coil, both cleared Nov. 20. The other, a surface coil called Cardiovascular Array from W. L. Gore and Associates, cleared Nov. 27. GE received a 510(k) clearance for increased gradients (15 mT to 25 mT) and slew rate (SR 25 to SR 40), as well as a diffusion imaging option, on its open-style Signa OpenSpeed Nov. 20.

In ultrasound, four devices passed FDA muster. These included a diffractive energy imaging system (SCAN 12/26/01) from Advanced Diagnostics, which was cleared Nov. 14, and Sonotech's transducer technology, called Scantac membrane, which was cleared Nov. 13. Two new sonography systems also passed. Toshiba's general-purpose Aplio, passed Nov. 13, employs a wide array of probes, including flat linear, convex linear, and sector arrays with frequency ranging from 1 MHz to 12 MHz. Medison's general purpose midrange SonoAce 8000 cleared Nov. 16 (see page 2 for product details).

Two devices cleared in each of three categories: CT, nuc med, and radiation therapy. GE's 16-slice CT scanner LightSpeed passed Nov. 8; Siemens 16-slice Sensation 16 passed a day earlier (SCAN 12/26/01). Philips' ADAC Labs business unit received clearance Nov. 7 for its open-style hybrid PET/CT Gemini (SCAN 12/26/01) and a day earlier for enhancements on its SKYLight gamma camera. SKYLight was modified to accommodate two separate patient tables, allowing the simultaneous head scanning of two patients. In radiotherapy, IMPAC Medical Systems received clearance Nov. 7 for its QwikSIM virtual simulator for patient image review, target and crucial structure delineation, and geometric treatment planning. Two days later, Standard Imaging got the nod for its IVB 1000 Well Chamber, which measures radiation coming from brachytherapy sources, both gamma and beta.