FDA clearances boom in April with submissions of multiple devices

Asian manufacturers clear MR and CT scanners

The FDA in April cleared 23 radiological devices, slightly under par for the same month in previous years (24 in 2000 and 26 last year) but a welcome uptick from March, which sank to 17. Even better is the possibility that this number may be an understatement, as several vendors cleared multiple devices under a single premarket notification.

Also notable in April was the number of stand-alone systems cleared: five of the eight ultrasound devices; one of four MR products; one of two CT devices; and the only x-ray product. There were also five image management products, a nuc med device, and two radiotherapy products.

The MR and CT scanners stood out as much for the companies making them as for the technology. Both come from Asia. The Isaac 1.5T system is made by Chi in TaeJon, Korea, and is equipped with six receive-only coils for the knee, shoulder, neck, wrist, and spine. The CT-C3000 Spiral scanner is made by Neusoft Digital Medical System in Shenyang, China.

GE had the only other CT product cleared by the FDA, a family of software options called SmartScore 3.5/4.0/4.5. The software, which runs on GE's Advantage Windows workstation, helps characterize calcified plaques in coronary arteries visualized in CT images. Regions of interest are selected manually or semiautomatically. SmartScore then calculates the calcium scores, generates patient reports, and adds the information to a patient database for future reference.

Other MR clearances included a trio of internal coils developed by Surgi-Vision. These intracavitary coils, all members of the Intercept family, are designed for use in specific anatomic regions: the esophagus, urethra, and vasculature. Signals received by the coils are transmitted to the scanner through a small coaxial cable and interface to a standard surface coil connector. The coils are encased in polymeric housings to protect against body fluids. All three devices are designed for use with Siemens 1.5T scanners. Earlier versions of each have been cleared by the FDA over the last two years.

Odin Medical Technologies, developer of an MR scanner dedicated to surgery, won clearance for a receive-only surface coil called FlexiCoil. The single-use device is designed to work with the company's PoleStar N-10 MR imaging system. The malleability of the coil provides better image uniformity and better overall signal-to-noise ratio, according to the company, when imaging structures near the surface of the patient's head or extremity.

Interventional MR has a new tool. The MR Mammography Intervention Aid by Machnet consists of a transparent acrylic plate containing about 600 puncture holes, 4 mm in diameter, held in a frame containing a set of MR markers. The device is designed for attachment to a bilateral open breast coil, also made by Machnet, to aid in placement and depth for needle insertion.

The OEC 9800 Plus, like its predecessor, is a mobile C-arm. The unit, made by GE-OEC, provides fluoroscopic and spot-film imaging and may be used for diagnosis or as a guidance tool during surgical or interventional procedures. Among its intended applications are cholangiographic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures.

GE also added the Vivid 3 Pro and Expert to its ultrasound Vivid 3 family. The Expert version provides more features as standard equipment. The Pro version, having fewer base options, allows features to be added as desired. Both are general-purpose ultrasound systems supporting cardiac, peripheral vascular, transesophageal, abdominal, gynecologic, urologic, fetal, pediatric, and small parts scanning. They can also be used for intraoperative, musculoskeletal, transvaginal, and transrectal procedures. The Pro and Expert consist of a mobile console with digital beam former and assorted electronic array transducers.

The U-2000 ultrasound system from U-Systems acquires and reconstructs data into 3D images. The product, which can perform pulsed Doppler, is specific to abdominal, small parts, peripheral vascular, and musculoskeletal imaging. The 50S Tringa system, a general-purpose scanner from Pie Medical, also passed FDA muster. A 3D imaging mode from Biosound Esaote and a musculoskeletal indication for the company's AU6 scanner obtained clearance. CrossPoint TransAccess Catheter, an ultrasonic imaging catheter, was cleared to facilitate the placement and positioning of catheters within the peripheral vasculature. The new device, developed by TransVascular, provides an intraluminal, cross-sectional ultrasound image. Two ophthalmic diagnosis systems, developed by Tomey Corporation USA, were also cleared.

The nuc med community will have a new software program for the display of wall motion and quantification of left ventricular function. The product, called the Northwestern Gated Blood Pool SPECT Software and being marketed by Syntermed, is designed to work with data obtained during gated technetium-99m blood pool SPECT.

Radiotherapy usually accounts for many, if not a majority, of clearances. In April, this category included only a remote-controlled radionuclide applicator system and a motion-tracking system. The HDR Miami Applicator, developed by Mick Radio-Nuclear Instruments, is designed as an accessory to brachytherapy systems to assist in the intracavitary delivery of radiation therapy to the cervix. The motion-tracking system, developed by Accuray as an option to the CyberKnife System, is designed to allow the treatment of lesions that move during respiration. The goal is to shorten treatments and reduce the exposure of normal tissue to radiation by using smaller beam margins.

EchoTech 3D Imaging Systems received clearance on a series of products: the Easy3D family, 3D FreeScan, EasyArchive, QuantiCon, and EasyStress. All address ultrasound images. The Easy3D family acquires heart cycle triggered or nontriggered sequences of 2D

images, then converts the data into 3D images. The 3D FreeScan system acquires, stores, and retrieves digital dynamic 3D ultrasound image data sets. EasyArchive digitizes 2D ultrasound images singly or in sequences from the video output port of an ultrasound scanner and stores them on hard disk or removable media. QuantiCon acquires heart cycle triggered or nontriggered sequences of 2D ultrasound images. In the sequence of images, multiple regions of interest can be selected. Inside these regions, the average gray value or the number of color pixels is calculated over time. EasyStress acquires 16 sequences of images (four stress phases of each of four standard views of the heart). The sequences can be synchronized and replayed either as sorted images after stress phase or as standard views.

The eFilm Workstation with Modules, developed by eFilm Medical, is composed of software that provides viewing and manipulation of diagnostic images. The product receives digital images and data from various sources, including digital imaging modalities, as well as secondary devices. In addition to routine processing functions, the product allows the overlay of templates to assist in preoperative planning.

Fusion7D, a software package developed by Mirada Solutions, runs on a standard PC platform and aligns pairs of images from different modalities, such as CT and SPECT. The geometric alignment allows the fusion of these images into a set of data that correlates the structures seen anatomically with the physiological activity detected in functional images.

Barco cleared three devices through the FDA in April. Its MediCal LE is a digital image quality management system, designed to calibrate and quality check color displays. The ImageDesk is a display system optimized for digital images. The MFCD 118i is a flat-panel display designed for use within MRI environments.