FDA clearances surge in September across varied technology types

Major nuc med, x-ray, ultrasound systems appear

Technology segments were equitably represented in September FDA clearances, which for the second month in a row reached or surpassed 25. Not since December 2001 and January 2002 has the radiology industry been able to string two such months together. More may be on the way, as vendors typically submit increasing numbers of applications in preparation for end of year commercial launches timed with the RSNA meeting. Not all devices that clear the FDA go immediately into commercial launch, just as all those clearing the agency in fall and early winter may not be commercially unveiled on the RSNA exhibit floor. But most will.

Among the likely debutantes at this year's RSNA meeting is GE's Road Warrior PET/CT, one of two nuclear medicine products to pass FDA review in September. Road Warrior is the Discovery LS PET/CT in a mobile configuration. The hybrid includes a LightSpeed Ultra multislice CT, which provides anatomic landmarks as well as data needed for nonuniform attenuation correction of PET images.

The other nuc med device to pass review, GE's Quasar, is a stationary device designed for general nuc med procedures. The company equates this system with the CT-based Hawkeye option for dual-head variable-angle gamma cameras GE developed with Elscint and the Elscint Apex VariCam. Quasar is capable of planar and tomographic gamma scanning, as well as coincidence positron imaging. Optional features include CT-based attenuation correction and functional anatomic mapping, assorted collimators, gating by physiological signals, and real-time automatic body contouring.

Among the standouts in the x-ray segment was the Imperium mobile C-arm from Westbury, NY-based Elmstech. The device consists of a C-arm stand and monitor trolley. Imperium operates in

fluoroscopic and radiographic modes and can be used for diagnostic, surgical, and interventional procedures. Applications include digital subtraction angiography, as well as orthopedic, neurologic, abdominal, vascular, cardiac, critical care, and emergency room procedures.

Also passing FDA muster was GE's OEC FluoroTrak 9800 Plus. The FluoroTrak surgical navigation feature is designed as a surgical aid. The system integrates the InstaTrak 3000 system with a FluoroTrak module, which is marketed by Visualization Technology, into the workstation of the OEC 9800 mobile imaging system. The InstaTrak 3000 is an image guidance system intended for use during sinus, skull base, cranial, and axial skeletal procedures. InstaTrak allows the surgeon to view reconstructed 2D images in the context of an electromagnetically tracked surgical instrument.

Instrumentarium Imaging won clearance to market its Delta 32 with optional add-on Delta 32 TACT (tuned aperture computed tomography), a digital mammography spot and 3D imaging system. Delta 32 and Delta 32 TACT are designed for use on the company's Diamond mammography system. Alternatively, a PC workstation running Delta 32 and Delta 32 TACT can be used as a stand-alone unit for viewing digital mammograms.

The FDA also cleared the Breast Bolster from Bristol, CT-based Beekley. The device is designed to enable stereotactic breast biopsies on thin-breasted patients.

Five image management devices passed agency review. The Viatronix V3D Explorer is designed to create 2D and 3D images of CT, MR, PET, and SPECT data. Volume, linear, and angular measurements allow the evaluation and quantification of tumors or selected organs. Other measurements include angular location/displacement, evaluation of hard and soft tissues, as well as internal structures including polyps, lesions, implants, fractures, aneurysms, and stenoses. The system also supports the interactive segmentation of any organ by removing specific structures from display for critical evaluation of those selected parts.

Rounding out the image management segment are Agfa Impax workstations featuring multiplanar reformatting, digital subtraction, and 3D options; a DICOM controller for Agfa's LR 5200 laser film recorder (capable of transmitting image data to the recorder at up to 100 Mb/sec); and an x-ray film processor from Fischer Industries of Geneva, IL.

Radiotherapy, like image management, had five FDA clearances in September. Philips AcQPlan 5.0 is an integrated 3D planning and simulation system embedded in a volumetric image-processing computer. The system plans radiation therapy using linear accelerators or other sources of teletherapy in the 4 MV to 50 MV range. The treatment planner simultaneously visualizes target and normal tissues in the context of 3D dose distributions.

A second treatment planning system, called PrecisePlan 2.00, also cleared the FDA. This system, developed by Precision Therapy International of Norcross, GA, is the latest iteration of the company's PrecisePlan platform, which provides 2D and 3D planning capabilities. An option supports intensity-modulated radiation therapy.

Other radiotherapy devices include software from Orange City, IA-based Med-Tec, which translates a treatment plan into G code

for use on a milling machine to produce a compensating shield; Nucletron's Kuske breast applicator set, which is designed for use with interstitial breast brachytherapy; and the LAP Dorado CT-4 Patient CT simulation isocenter and field marking system from LAP of America in Boca Raton, FL.

An eight-channel cardiac phased-array coil from GE led the MR segment. (This group included three other coils, all from MRI Devices: one each for the wrist, spine, and knee.) GE's cardiac coil, which covers the heart and mediastinum, is a modification of a GE phased-array coil already cleared by the FDA. This latest version offers eight independent receive channels instead of four, integrates preamplifiers, and utilizes ASSET optimized geometry for parallel data acquisition.

In CT, GE won regulatory clearance to market its Smart Breath Respiratory compensation option. Smart Breath improves clinical images by reducing organ and tissue motion related to patient respiration during a CT acquisition. The software allows the user to retrospectively define the best respiratory phase from an image quality standpoint and then group the images by the phase selected. The other CT product to pass review is CalScoR, a Windows-compatible software product that specifies the location of calcium in CT images, calculates the calcium score, and issues reports.

One of the three ultrasound devices clearing the FDA is a handheld unit, called SuperNova. (The others are probes, a transvaginal probe from Vascular Control Systems of San Juan Capistrano, CA, and a Doppler flow probe from Cook Vascular.) The general-purpose system, developed by Novasonics of Mountain View, CA, includes a 3 x 4-inch personal display unit and an imaging unit that accommodates a removable transducer. The screen is held in one hand, the imaging unit in the other. A docking station provides holders for the display, imaging unit, and transducer modules, as well as battery chargers. The device is suited to a variety of clinical applications, including fetal, abdominal, intraoperative, pediatric, small organ, neonatal, transrectal, transvaginal, transesophageal, cardiac, and peripheral vascular imaging. Equipped with Doppler and harmonic imaging, the SuperNova is equivalent, from transducer and user perspectives, to Philips' HDI 5000 and GE's Logiq 9, according to the company.