FDA clearances in March show rise in number and quality

'Boris Platform' from Philips hints at 3D

FDA clearances in March edged up to 24, three more than the previous month and in line with or better than March performances over the preceding two years. Clearances were spread evenly over several categories. Radiotherapy led the pack with seven (most of which related to brachytherapy), but MR, ultrasound, image management, and x-ray each had four. CT had one.

Among the most intriguing in the latest crop of FDA-cleared devices is the "Boris" platform, a general-purpose mobile software-controlled ultrasound system developed by Philips Medical Systems. Philips cited its HDI 5000 as the predicate device. Vendors commonly associate new products with established flagships when putting together FDA submissions; the Boris platform appears to have much of the horsepower found in Philips' premium scanner.

Philips noted in its FDA application that Boris uses essentially the same technologies as the HDI 5000 for imaging, Doppler, and signal processing. Specifically, it offers 2D, M-mode, color Doppler, color M-mode, color power angio, CW Doppler, tissue Doppler, pulsed tissue Doppler, and pulsed Doppler imaging. Most telling, Boris is compatible with 17 transducers, including the company's xMatrix multidimensional phased-array transducer-a critical component of Philips' Live 3D Echo. This dedicated 3D cardiology feature, built into Philips' Sonos 7500, was launched late last year (SCAN 12/25/03).

Clinical applications for the Boris platform go far beyond cardiology, according to Philips' FDA filing. They include general adult and pediatric imaging, as well as vascular, ob/gyn, and intraoperative applications. The new product supports phased, linear, and curved linear arrays; features transesophageal echo; and includes motorized 3D curved linear arrays, as well as pencil probes, which generate data but not images. The Boris system cleared by the FDA allows the measurement of anatomical structures and provides analysis packages to assist in diagnoses.

The console includes a user interface, display, system electronics, and optional peripherals such as printers and VCR. The interface includes the usual complement of knobs and buttons, as well as a touch panel for less frequently used functions and an alphanumeric keyboard to input patient data and other text.

Diagnostic Ultrasound of Newtown, CT, won clearance for its BladderMass BVM 6500, which generates sonograms of the bladder. The handheld, battery-powered unit collects cross-sectional images of the bladder from 24 scan planes, then constructs a model of the bladder and automatically computes the volume of urine. Physicians traditionally have used a standard ultrasound system to make random bladder measurements in order to calculate bladder volume.

March standouts in x-ray included the Vidar Bone Track System, which processes digital radiographs to facilitate the selection and ordering of orthopedic implants. The software allows semi-automatic ordering by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software, which runs on a stand-alone or hospital network workstation, also tracks components and provides postoperative patient follow-up using digital images.

FDA reviewers passed Hologic's Lorad MultiCare Platinum device, which combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system. The hybrid device is applicable for use in first localizing and then supporting fine-needle aspiration or core biopsy of suspicious lesions.

GE Medical Systems received FDA clearance for a new member of its long-standing OEC 9800 mobile C-arm family. The new OEC 9800 E/CV+ Digital Mobile Imaging system is designed to provide fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures. Features specifically address diagnostic and interventional cardiac imaging, as well as cholangiography, endoscopy, and urologic, orthopedic, neurologic, vascular, critical care, and emergency room procedures. The new product is made up of two parts: a C-arm stand and a workstation. The C-arm can follow linear as well as rotational routes across the patient. Interfaces to peripheral devices include an auxiliary connection that supports a Medrad angiographic injector to facilitate synchronized acquisition of angiographic images during contrast media injection.

GE also received clearance for an updated version of its LightSpeed 16. FDA paperwork describes the system, dubbed LightSpeed 5.0 CT, as being "substantially equivalent" to the earlier 4.0 version, GE's 16-slice scanner now in commercial production. Like its predecessor, the LightSpeed 5.0 is designed for head and whole-body CT applications.

GE achieved two notable scores in MR. FDA reviewers cleared a version of the company's Signa 3.0T Infinity TwinSpeed equipped with Excite. This latest iteration of the very high field scanner differs from its 3T predecessor primarily in the addition of eight independent receive channels and a dual-mode gradient coil, as well as an increased bore diameter, according to GE's FDA filing. Also clearing the FDA was GE's 3T torso phased-array coil, a four-channel phased array receive-only coil designed for use on the company's 3T MR system. Primary applications are for the thorax, abdomen, pelvis, and prostate. The new torso coil is essentially a larger version of the company's 1.5T cardiac phased-array coil.

Philips Medical Systems received clearance for an updated version of its Intera family of MR scanners, which operate at 0.5T, 1T, 1.5T, and 3T. New functionality includes diffusion tensor imaging, which differentiates tissues with restricted diffusion from tissues with normal diffusion; a Windows operating system in place of the old VMS technology; and enhancements related to the data processing, such as a larger memory.

Among image management technologies to pass FDA muster in March was the Obsidian PACS. The new product, which was developed by Obsidian Medical Technology of Pleasanton, CA, can connect to either analog or digital devices to acquire, transmit, view, and store imaging data. Its 3D ultrasound image router captures and stores 2D images from an ultrasound system and reconstructs them into 3D for obstetric exams. The company noted, however, that the 3D images provide only an approximate representation of the volume and should not be used in diagnosis or when making quantitative measurements.