FDA clearances boom to 10-year high in January

Ultrasound products claim spotlight

In the 10-year stretch from 1993 to 2003, the most radiological clearances in the month of January occurred in 1998, when the FDA cleared 29 of these devices. This record was tied last month.

Lately, New Year's Day has signaled a downturn in the number of products cleared. From 1999 to 2001, the agency sanctioned fewer than 20 devices in each year's first month. Last year, the number struck an unusually high 25, which in turn was eclipsed by this year's total.

Image management systems accounted for 10 of January's 29 clearances. Most were software-based PACS or postprocessing packages. Three were modality-specific: one each for nuclear medicine, x-ray angiography, and ultrasound. MR had six clearances, five of them coils.

Ancillary devices, such as a multileaf collimator, boosted radiotherapy into third place with five clearances. Four x-ray devices made it through FDA review; one was for dental applications. Three new ultrasound systems were cleared, as well as a gamma camera. CT was blanked.

One of the ultrasound systems, the Picus 3D from Pie Medical of Maastricht, the Netherlands, supports cardiac, peripheral vascular, fetal, neonatal cephalic, small organ, and abdominal as well as transrectal and transvaginal scanning. The Picus family sits atop Pie Medical's line of compact and portable systems. Until now, the company has positioned the Picus scanner for use in women's health, even though the product line could be configured for general radiologic and cardiac exams.

B-K Medical, a Copenhagen, Denmark-based subsidiary of Analogic, won clearance for its latest ultrasound system, the model 2400. The system, like its multipurpose predecessor Hawk 2102, supports shared service scanning. Specifically, the new system can be used to perform vascular, urology, cardiology, and ob/gyn exams, as well as to guide biopsy and puncture needles. It supports linear, convex array, and mechanical sector transducers.

TeraTech of Burlington, MA, received clearance to market the company's latest development, the Terason 2000/BAS portable system. New indications of this configuration include guidance for the placement of needles and catheters; transvaginal biopsy, infertility monitoring of follicle development, and amniocentesis.

A standout among the MR clearances was the Aurora MR-Guided Interventional System. The device, developed by Aurora Imaging Technology of North Andover, MA, includes a base plate system and components, needle guidance stage and components, position display unit, and target planning software. A 3D crosshair is mounted near the needle guide in a fixed and known location. The stage is moved until the needle guide and fixed crosshair are positioned in the general vicinity of the lesion.

The interventional device, an optional accessory to Aurora's dedicated MR mammography system, is designed as an aid in performing minimally invasive procedures on the lateral or medial side of either breast and adjacent anatomies.

The cleared gamma camera was developed by GVI Medical Devices of Twinsburg, OH. Called OnePass, the system acquires and processes gated first-pass images of the heart. It consists of a single, small field-of-view detector mounted on an articulating arm. A vertical lift adjusts the height of the detector to match changes in the incline of the treadmill, thereby ensuring it can be properly positioned over the heart.

GE Medical Systems received permission to market mobile versions of its Innova 2000 and 2000S cardiac cath systems built around digital flat panels. The mobile versions, like the fixed configurations, support diagnostic and interventional cardiac angiography and can be fitted out to perform rotational angiography. Although equipped for mobile operation, the newly cleared products can be installed in fixed sites.

GE may soon bring to market a new computer workstation to handle nuclear medicine and hybrid imaging. The workstation supports emission tomography in planar imaging, whole-body imaging, SPECT, and coincidence positron imaging. It corrects for attenuation and registers anatomical and physiological images. The product consists of a PC platform running Windows 2000 equipped with a read-write CD and an Ethernet network connection. Optical disk and DVD archives are optional. The company has dubbed the workstation "Jupiter," but the product name will likely be something else. The currently marketed forerunner of Jupiter, GE's eNTEGRA workstation, had been called "Einstein" when cleared by the FDA.

Instrumentarium Imaging received clearance for a breast biopsy and lesion marking system. The new product is designed to work with the company's Performa mammographic system, ergo the name Performa Stereo. The new product is especially suited for fine-needle aspiration, core biopsy, vacuum-assisted biopsy, and lesion marking. A mechanical docking interface connects the Performa Stereo adapter and biopsy unit. With the new product, x-ray images are taken at 15º above and below the region of interest in the breast. Image capture

is accomplished with an 18 x 24-cm film cassette. A motorized Cytoguide unit drives needle targeting. Corresponding images are shown side by side on a film reader and the target point is marked on each image. The film marker unit then calculates xyz coordinates. The needle holder is automatically positioned, taking into account the coordinates and the selected needle length. The tip of the needle can then be inserted into the holder.