February sustains forward progressDespite being the shortest month of the year, February has typically been a good month for FDA clearances. This year, regulators slowed a bit, clearing just 22 products for marketing in the U.S.
February sustains forward progress
Despite being the shortest month of the year, February has typically been a good month for FDA clearances. This year, regulators slowed a bit, clearing just 22 products for marketing in the U.S. compared with 27 a year ago and 28 in 2000. The slowdown was understandable, however, considering the strength of the preceding month (SCAN 3/6/02).
As they did in January, MR devices accounted for most clearances. But the modality's domination was reduced to the barest lead as MR edged out ultrasound six to five. X-ray accounted for four clearances, image management for three, nuclear medicine two, radiotherapy and CT one each.
The numbers for x-ray and image management were skewed slightly by the inclusion of two dental products: a computed radiography system that scans phosphor plates in place of dental x-ray film and a dental PAC system. Other products in image management were GE's Advantage Workstation 4.1 and PACS software called ViewSend from KLT Telecom of Chantilly, VA. In the x-ray category were Siemens' Axiom Aristos FX, which was unveiled at the European Congress of Radiology (SCAN 3/20/02), two portable units from Sedecal USA, and a CCD camera-based digital fluoroscopy upgrade from Infimed.
Nuclear medicine clearances comprised a handheld gamma finder from the German firm Silicon Instruments designed to guide surgeons, and the latest iteration from Anaheim-based Syntermed of the Emory based CP Medical for introducing radionuclide seeds.
CT gained an upgrade kit that bumps the Toshiba Aquilion from four to eight slices. Oddly, this is exactly what executives at Toshiba told DI SCAN at the RSNA meeting they were not going to do, preferring to leapfrog over eight to 16 (SCAN 12/26/02).
Ultrasound clearances included four scanners and a lotion for coupling the patient and transducer. Hitachi cleared two devices: the EUB-8500 and EUB-6500. Both are capable of harmonic, superficial musculoskeletal, and 3D imaging. Siemens obtained clearance for its shared services product Omnia X/XS, an iteration of a system already in its product line. The agency also cleared GE's Logiq 3, a compact general-purpose system.
Four of the six MR devices cleared by the FDA were coils. These included a shoulder coil and a body and spine coil from USA Instruments; a small extremity coil from MRI Devices; and a breast coil from Machnet in the Netherlands. Filling out the category was an orthopedic scanner from Biosound-Esaote and neurovascular analysis software from Chicago-based VasSol. Esaote's E-Scan XQ is an enhanced version of the currently available E-Scan, marketed in the U.S. primarily through GE Lunar. The software package, called CANVAS N-VAS-D 2.0, measures blood flow, identifying vasculature in 3D reconstructions generated using time-of-flight MRI images. N-VAS-D creates a Web browser-compatible report that shows both flow results and images.