Industry maintains red-hot pace with August FDA clearances

Major systems appear in all modalities but CT

The imaging industry's good fortunes at the FDA continued to accrue in August, as the watchdog agency cleared 32 devices for marketing in the U.S.-two more than the month before. The number of clearances so far this year, 208, is well ahead of the number obtained through August last year (178) and the year before (192). It is just three behind the pace set in 2000, the last time the agency's Office of Device Evaluation cleared more than 300 radiology products in a year.

Clearances were spread across several categories, with image management and radiotherapy accounting for eight each, MR six, x-ray five, ultrasound three, and nuclear medicine two. No CT devices were cleared by the FDA in August.

Among the nuclear medicine devices cleared in August 2003 was the PEM 2400 PET Scanner, a high-spatial-resolution, small field-of-view PET imaging system specifically developed for close-range spot imaging. Developed by PEM Technologies of Rockville, MD, the partial-ring PET scanner is equipped with two lutetium-containing gamma ray detectors intended to image and measure the distribution of positron-emitting radiopharmaceuticals. Not a whole-body system, the device is limited to recording radionuclide activity in selected areas of the body.

GE Medical Systems obtained clearance for a digital fluoroscopy system. The Innova 3100, which is indicated for both diagnostic and interventional angiography, was described to the agency as being substantially equivalent to the currently marketed lnnova 4100, which gained 510(k) clearance late last year.

The detector in this latest member of the Innova flat-panel family is, like its brethren, composed of amorphous silicon with a cesium iodide scintillator. The digital data are sent through a fiber channel link to an acquisition component and then to a network for such applications as postprocessing, printing, viewing, and archiving.

The Innova 3100 consists of an angiographic monoplane positioner, a table, an x-ray system, and a digital detector. The gantry, called InnovaTrace, includes capacitive sensor technology and optimized collision avoidance software that permits pivot and C-arm speeds up to 20 inches per second. The system can perform conventional and, optionally, rotational angiography, according to the FDA filing.

The dimensions of the new detector were not included in publicly accessible documents, but GE may have provided a hint in the name of the product. The company has set a precedent of alluding to the size of the detectors in their product names. The Innova 4100 has a flat-panel detector measuring 41 x 41 cm; the Innova 2000 has a 20 x 20-cm detector.

Toshiba's new Excelart Vantage (SCAN 9/24/03) was among the FDA's MR clearances. The new product differs markedly from the company's existing Excelart 1.5T system, sporting hardware that includes an ultrashort-bore magnet and gradient coils changed to match the short bore. The patient couch is wider and features a detachable top, which can be combined with a gurney. The whole-body coil was modified to correspond to new SAR (specific absorption rate) specs. A four-channel flex-body array coil is optional. A quadrature head coil supports parallel imaging with the company's Speeder technology. The new scanner also has the ability to display gating waveform on the side of the gantry. Software differences relate to the central processing unit, radio-frequency coils control, noise control, and SAR limitation.

Also in MR, Biosound Esaote received FDA clearance for a modified version of its E-SCAN XQ. The scanner, which is optimized for orthopedic exams, includes a modified system configuration, upgraded electronics, and a new software release.

Medison obtained clearance for its SA-9900 Plus, a general-purpose mobile, software-controlled diagnostic ultrasound system. The system displays B-mode and M-mode as well as color-flow, continuous, pulsed, and power Doppler. The SA-9900 Plus uses digital beamforming technology and supports a variety of linear, convex, phased-array, and static probes. It was cleared with 13 different transducer models. Any four transducers can be connected simultaneously. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each may be inserted by the operator and stored for recall. Customization options include transmit focusing, filtering, image enhancement processing, and dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Biopsy guidelines are provided onscreen to assist in the collection of tissue samples, using biopsy guide adapters offered as optional accessories.

Several image management systems were noteworthy. Erad Imagemedical of Palo Alto, CA, was cleared to begin marketing its PracticeBuilder 1-2-3 PACS. The system includes a Gateway server, a central system manager component, a diagnostic workstation component, and an archiving component. Patient and procedure information is delivered to the central system manager, followed by acquisition of the image data directly from the modality or by one of the acquisition components. After receiving the data, the central system manager searches for and retrieves relevant prior procedure data from the archive component. When the central system manager registers the acquired images and prior procedure data, the information can be accessed from the operator work list.

Software that permits orthopedic surgeons to preplan surgical procedures was cleared. The product, called Orthoview, was developed by Meridian Technique of Basingstoke, U.K. The system permits image viewing, manipulation, and the overlay of prosthetic templates on a PACS or stand-alone workstation. Orthoview can record, store, and retrieve the templating process steps typically used by surgeons when assessing the optimal prosthetic device for a patient. It does not, however, specify the requirements for the prosthetic template, which the company noted is the responsibility of the prosthetic manufacturer.

Nucletron won FDA clearance for two devices. The Oncentra Treatment Planning (OTP 1.2) system is used to analyze and plan radiation treatments in three dimensions. The software estimates dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by medical staff. OTP 1.2 uses externally acquired medical images and user input. The software runs on a Windows XP platform.

Also clearing the FDA in August was Nucletron's Swift 2.0, a real-time treatment planning system for brachytherapy of prostate cancer. The program provides a variety of plan evaluation tools to assist in determining optimal dose distribution. These deliver anatomical and dosimetric information to determine the positioning and loading of radioactive sources prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading.

Viatronix of Stony Brook, NY, is clear to market its V-3D Explorer. The software was presented to the FDA as an image-processing option to the company's V-3D visualization system. Viatronix V-3D Explorer displays 2D/3D visualizations of CT, MRI, PET, SPECT, and digital x-ray data and performs various calculations intended for the evaluation and quantification of tumors or selected organs. These include volume/linear measurements, angular location/ displacement, study/analysis, and evaluation of both hard and soft tissues, as well as other internal organ structures for polyps, lesions, mass, implants, fractures, aneurysms, and stenoses. It also supports the interactive segmentation of any organ by removing certain structures from display for critical evaluation of selected parts of organ.