Products receiving FDA clearance foreshadow offerings at RSNA show

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.

Ultrasound

• Sonoreal 3D (Bio Medi Com, Sept. 26). The 3-D add-on product, which plugs into any ultrasound system via a video-out socket, was cleared for gynecological applications. The FDA cleared the platform in mid-2000 for general purposes.
• SonoAce 9900 (Medison America, Sept. 12). The device is a general-purpose software-controlled ultrasound system. Clearances specifically cited three transducers: phased, curved linear, and linear array. The system cleared the FDA in August 2000.
• SonoAce 6000II (Medison America, Sept. 12). The general-purpose software-controlled system comes equipped with as many as five transducer models.

Radiotherapy

• Intra Operative Radiation Therapy System (Arplay Medical, Sept. 21). For use during surgical procedures, the product consists of several treatment cone localizers, a selection of collimators, and a telescopic device that connects the cones to the linear accelerator, aligning the electron beam with the center of the cone.
• Mini Multileaf Collimator (MRC Systems, Sept. 7). The conformal radiotherapy/radiosurgery device is mounted on a standard linear accelerator. The tungsten leaves of the collimator change shape at different gantry positions, depending on the treatment protocol generated with planning software. The collimator shapes allow delivery of well-defined target volumes of radiation despite a steady dose of radiation.
• Accu-Space absorbable seeding spacers (CP Medical, Sept. 4). No details available.
• OmniDos (Scanditronix Medical AB, Sept. 5). In combination with a PC, the software-based dosimetry system measures dose distribution to provide acceptance testing, beam tuning, routine beam verifications, isodose tracking, and linear scans.

Image Management

• Rapidia (3D Med, Sept. 28). The image processing software is specific to DICOM-compliant CT and MR data. Rapidia allows real-time viewing, image manipulation, segmentation, 3-D volume and surface rendering, virtual endoscopy, and reporting.
• AETmed image processing software (AETmed, Sept. 21). The software-based system captures, retrieves, displays, processes, prints, archives, and transmits radiological and cardiological images. The product has four components: DICOMed DIG.IT, an image acquisition and CD recording station; DICOMed P@CS, an image archiving manager; DICOMed Review Cardio, a review workstation for cardiology; and DICOMed Review, a diagnostic review workstation for radiology.
• LR5200 modification (Agfa, Sept. 20). The laser film recorder has no changes in hardware or software. The 510(k) was a formality, clarifying indications for the device’s use for the FDA.

MRI

• Numaris 4VA15A (Siemens Medical, Sept. 27). This latest iteration of operating software is indicated for use on Siemens MRI scanners.
• QWH-420 wrist array coil modification (MRI Devices, Sept. 25). The existing coil for visualizing the wrist and hand was modified.
• Aurora (Aurora Imaging Technology, Sept. 19). Described to the FDA as a “forklift upgrade,” the Aurora MR Diagnostic Device features a new magnet that operates at 0.5 tesla, and improved radio-frequency and gradient subsystems. No changes were made to the software or pulse sequences running on the scanner. Both the preceding and upgraded models are dedicated to MR mammography.

X-ray

• ADC Compact Plus (Agfa, Sept. 28). This is an enhanced version of Agfa’s existing computed radiography product. Three major differences are the laser, a smaller spot size, and improved plate, which enhance throughput, resolution, and sensitivity. Other enhancements include the miniaturization and reorganization of electronics to make the unit more compact and reduce power requirements.

CT

• LightSpeed Plus Mobile CT (GE Medical Systems, Sept. 7). The mobile version has the same technological characteristics as the stationary configuration. Changes allow the scanner to be used in either a fixed or mobile environment.

Nuclear medicine

• Positrace/Discovery VI (GE Medical Systems, Sept. 18). The dual-mode PET and CT oncology system is comparable to the existing version of the Positrace/Discovery system. The hybrid scanner is designed as a diagnostic tool in which the CT enhances the radioisotope-based images by compensating for attenuation effects from photon transmission through the body. The CT and PET scanners can be used independently.
• GE Vision nuclear medicine workstation (GE Medical Systems, Sept. 6). The workstation is designed to display and assist in the analysis of planar and tomographic nuclear medicine images. The product was found to be comparable to GE’s Vision PowerStation nuclear medicine workstation.