Vendors win FDA clearance for 34 radiological devices

April 19, 2006

The industry rebounded in March from a sluggish start to the year as the FDA cleared 34 devices under 510(k) review, nearly matching the number cleared in the previous two months together. March brought the total to 72 radiological devices cleared so far in 2006, making up for the slow start and putting vendors on track with previous years.

The industry rebounded in March from a sluggish start to the year as the FDA cleared 34 devices under 510(k) review, nearly matching the number cleared in the previous two months together. March brought the total to 72 radiological devices cleared so far in 2006, making up for the slow start and putting vendors on track with previous years.

Most clearances were in image management, which notched 10. Radiation therapy had eight. X-ray had four. Ultrasound, MR, nuclear medicine, and dental each had three.

Among the makers of image management systems, Medicim of Belgium received clearance for a software interface and image segmentation system designed to support the transfer of imaging information from CTs and other scanners. The software is particularly designed for surgical planning and simulation of maxillofacial procedures. The Maxilim software suite supports rendering of hard and soft tissues and visualization of CT slices. It includes basic annotation and measurement tools.

Vital Images got the regulatory green light to sell its Vitrea2 Version 3.8.1, featuring Fusion7D, which registers anatomic and functional volumetric data, and RTist, software designed to display and visualize multimodality 2D and 3D images. Also integrated into this version is R2 Technology's ImageChecker CT Lung Nodule V2.0, a computer-aided detection system designed to assist physicians in soft-copy review of CT images of the chest. The AutoPoint Temporal Comparison Tool allows the viewing, analysis, registration, and comparison of several chest CT images. The Pulmonary Artery Patency Exam tool enables the viewing and analysis of low-density regions that may indicate filling defects or other intravascular abnormalities.

A low-resolution viewer developed by VuComp to allow review of CAD images cleared the FDA but its commercial release must await FDA approval of the company's CAD system. The M-Vu Viewer Station low-resolution display system is designed to support the review of screening and diagnostic mammograms. It connects to the M-Vu CAD Station via an Ethernet network to download selected radiographic images and CAD results or other annotations. The still-investigational M-Vu CAD system is designed to help doctors find subtle mammographic abnormalities, such as masses, architectural distortions, and calcifications, with a minimum of false positives.

In MR, Medrad won FDA clearance for a 3T endorectal coil. The eCoil Imaging System, designed to work with 3T scanners built by GE Healthcare, is a receive-only coil intended for high-resolution MR imaging and spectroscopy of the prostate.

Another surface coil, this one from Confirma, cleared the FDA for use in MR mammography. The Access Breast Coil 4/SMS is a four-channel phased-array receive-only radiofrequency coil designed to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues. The open design of the dual-purpose coil provides lateral, medial, and craniocaudal access to the breast for interventional procedures.

Spectrica of Ottawa, ON, can now market its Cyclone gamma camera for nuclear

cardiology. The device includes accessories such as signal analysis and display equipment, patient and equipment supports, and radionuclide anatomic markers.

The Cyclone camera incorporates dual fixed 90° detectors that sweep across a patient chair, recording radionuclide radiation in the energy range of 50 to 200 keV.

In radiation oncology, Direx Systems won clearance for its Migue positioning device, which uses x-ray registration to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy. The system consists of a main unit that incorporates two angularly spaced identical fluoroscopic imaging chains, mounted on a rigid ring, for acquisition of x-ray images; a console workstation, consisting of a PC with embedded software, used for control, display, and image processing; and an electronics cabinet.

Siemens can now bring to market its Oncor Expression with Coherence Workspaces, a linear accelerator based on the previously cleared Oncor Avant-Garde and Primus architectures. The new system features a next-generation amorphous silicon flat-panel portal imaging device called Optivue 1000ST. Coherence Therapist Workspace is a workstation consisting of task cards that allow a selection of modules of common software applications for image acquisition, reconstruction, postprocessing, display, and archiving. This release 2 introduces a new acquisition Megavoltage Cone Beam acquisition method that acquires 2D projection data, which are then processed into 3D using the Cone Beam reconstruction. The 3D data can be used by the Adaptive Targeting patient localization application, which supports alignment of 3D planning data with newly acquired 3D cone beam data for patient position localization and setup.

In the ultrasound category, Telehealth systems company cyberMDx is cleared to market its MDxNET, a mobile integrated IT system to allow remote physicians to perform triage, make diagnoses, and consult with and train onsite personnel through two-way audio and visual communication. MDxNET is designed for integration into remote, rural, sports medicine or primary care/internal medicine clinics, and emergency/disaster relief services. Prototypes were field-tested on the Space Shuttle and in Bosnia. The MDxNET features 2D and 3D ultrasound capabilities used to screen for internal injuries such as bleeding around the heart, ruptured spleens, and damaged kidneys. Images are sent to a remote site for interpretation, along with ECG data obtained using a wireless 12-lead sensor. MDxNET also offers an integrated electronic spirometer to measure baseline lung function and evaluate the effectiveness of medical treatment.