The number of device submissions that met FDA muster slumped in September, but clearances included several systems likely to be highlights at the upcoming RSNA meeting. The clearances were spread almost evenly across seven categories. Image management,
The number of device submissions that met FDA muster slumped in September, but clearances included several systems likely to be highlights at the upcoming RSNA meeting. The clearances were spread almost evenly across seven categories. Image management, radiation therapy, and MRI each garnered four clearances, CT and ultrasound received three, and x-ray and nuclear medicine each had two.
The number of September clearances-22, compared with 29 in August-was disappointing. Five of the clearances, however, will likely attract a lot of attention on the RSNA exhibit floor, even though they may not come as a surprise to industry observers.
Leading the pack will be Philips Medical Systems’ new Mx8000 IDT CT scanner. Its core Infinite Detector Technology (IDT) was unveiled at the 2000 RSNA meeting as a work-in-progress. Its Sept. 13 clearance by the FDA as part of a whole-body CT system came just weeks before government regulators on both sides of the Atlantic cleared the way for Philips’ acquisition of the system’s developer, Marconi Medical Systems.
The product sets a standard for CT scanning: 16 slices acquired simultaneously. Equipped with IDT, the Mx8000 helical scanner can cover more than 4 cm per second while achieving submillimeter isotropic resolution. That is 12 times faster than the current generation of quad-slice CT scanners, according to the company. Because of these capabilities, the system may be dedicated to cardiovascular applications, in which it will allow lesion characterization and measure ejection fraction and wall motion.
Oldelft will likely showcase its digital x-ray system, ThoraScan, which cleared the FDA on Sept. 19. The dedicated chest imager is built around slot-scanning technology. The detector is made of charge-coupled devices that scan a cesium iodide scintillator. The unit comprises a camera stand with detector, tube stand, control unit, x-ray tube, collimator, generator, and operator workstation.
GE Medical Systems will direct booth visitors to its new ASSET (array spatial sensitivity encoding technique) option for MRI, which received regulators’ nod on Sept. 24. Company executives have been talking about ASSET for much of the year, as a counter to Philips’ promotion of SENSE (sensitivity encoding). Used in conjunction with phased-array coils, ASSET promises to increase resolution and decrease scan time (SCAN 8/22/01). The FDA found ASSET to be substantially equivalent to the array processor subsystem and reconstruction techniques used on the Signa 1.5-tesla TwinSpeed, Signa VH/i, and Signa OpenSpeed.
AccuImage received FDA clearance on Sept. 25 for SmartGate, a retrospective CT gating module that allows quick and reliable section of slices for coronary calcium scoring. The software increases dose efficiency and decreases the complexity of the study, according to the company. This in turn reduces the time needed to review and report cases, enhances interpretation, and provides 3-D images that can be used for patient information or marketing of the site.
A 3-D-capable PACS from TeraRecon cleared the FDA on Sept. 13. AquariusNET combines the capabilities of the company’s VolumePro 3-D hardware and its image streaming network technology to deliver 2-D and volumetric images for review and analysis on multiple remote stations simultaneously. Competing PACS require specially designed workstations to process volumetric images, according to TeraRecon. The unique architecture of AquariusNET not only supports advanced processing capabilities, but allows the data to be accessed on desktop PCs.
Following are FDA-provided data on the other September clearances.