June was an off month for FDA clearances. Only six of the cleared devices acquire original image data: an MR scanner, an ultrasound system, a CT scanner, and three radiographic or radiographic/fluoroscopic products. The rest were upgrades to existing
June was an off month for FDA clearances. Only six of the cleared devices acquire original image data: an MR scanner, an ultrasound system, a CT scanner, and three radiographic or radiographic/fluoroscopic products. The rest were upgrades to existing systems, peripheral devices, or software packages.
Even the number was disappointing. Just 20 devices cleared the regulatory agency in June. This compares poorly with the 27 clearances issued in May. June had the lowest number of radiologic devices cleared since the agency passed 18 devices in January 2001. (For the past three years, January has been the slowest month for FDA clearances.)
June’s shortfall, however, might not have been the fault of regulators. The average time of review-the time from submission to final decision-was within or very close to the 90-day period afforded FDA reviewers by Congress. The lull, therefore, may have been the result of a slowdown in submissions.
Of the 20 products cleared in June for marketing in the U.S., five were in radiotherapy, four in ultrasound, three each in CT and x-ray, two each in MRI and image management, and one in nuclear medicine. Notable was Ultrasound Scanner Type 2102 from B&K Medical A/S. The scanner, which the FDA determined to be substantially equivalent to Siemens’ Sonoline Elegra, supports B- and M-modes, pulsed-wave Doppler, and color flow mapping, as well as tissue harmonic imaging. Optionally, an ECG signal can be superimposed on the ultrasound information in all modes and mode combinations. The 2102, which cleared on June 8, can perform simple geometric measurements, as well as calculations involving vascular, urological, cardiological, and ob/gyn applications. It can also be used to guide biopsy and puncture needles. The system was cleared with four transducers-models 8660, 8664, 8804, and 8805-providing a range of capabilities pertaining to ophthalmic, fetal, cardiac, and peripheral vessel imaging. Transducers are linear, convex, and mechanical sector.
Fonar’s Pinnacle was similarly impressive. The MR scanner is identical to the Fonar Quad 12000 four-post magnet system, except that the resistive magnet coils are replaced with superconductive magnet coils. The poles are arranged to establish a 0.6-tesla magnetic field with a limited fringe field. The signal-to-noise ratio is equivalent to the SNR of the Quad 12000. The open design of Pinnacle, which was cleared June 6, allows it to be used to guide interventional procedures. The scanner provides a considerable increase in magnet stability, according to the company, resulting in enhanced image quality and a major reduction in operating costs. Another advantage, according to Fonar, is the improved overall reliability due to the elimination of equipment commonly used for resistive magnets.