FDA clearances stabilize in March in mid-20s

May 18, 2004

Image management dominated FDA clearances in March, tallying 10 of the 24 approvals, but only a handful were for full-blown PACS. The rest were for specialty software, mostly algorithms designed to improve the handling of data from a specific

Image management dominated FDA clearances in March, tallying 10 of the 24 approvals, but only a handful were for full-blown PACS. The rest were for specialty software, mostly algorithms designed to improve the handling of data from a specific modality.

Overall, the industry fared well-one ahead of the previous month and in line or better than the number cleared in March for each of the previous three years. Standouts among the crop of clearances were three ultrasound systems, each one fitted for a wide range of applications. Clearances in x-ray, MR, CT, ultrasound, and nuclear medicine stayed in the low- to mid-single digits. Radiotherapy, which typically garners a substantial number of clearances, accounted for just one in March.

Siemens Medical Solutions received clearance on a general-purpose, software-controlled ultrasound system capable of B-Mode, M-Mode, 3D, and harmonic imaging. The new product, dubbed the Ebisu, supports general radiology, abdominal, small parts, transcranial, ob/gyn, cardiac, pelvic, neonatal and adult cephalic, urology, vascular, musculoskeletal, and peripheral vascular applications. It also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnosis. Clearance cited 12 transducers. Two are endocavitary, one of which was designed with a mechanical sector 3D transducer. The system also includes a convex array, mechanically driven, 3D transducer.

Esaote's Model 7300 is a compact ultrasound system capable of B-mode, M-mode, Doppler, and color flow mapping. The Model 7300 can perform Tissue Enhancement Imaging, utilizing low-frequency probes. It can drive phased, convex, and linear array probes and is equipped with a CD-RW disk drive for image storage. Data can also be stored directly to a PC via a LAN port. The compact system supports cardiac, transesophageal, peripheral vascular, neonatal and adult cephalic, small parts, musculoskeletal, abdominal, fetal, transvaginal, transrectal, and pediatric examinations.

Aloka's SSD-4000 is a general-purpose system with gray-scale and Doppler capabilities. The high-midtier product was cleared as being compatible with 28 transducers.

Sectra's Angiography and Cardiology Package exemplifies image management software designed to support a specific modality. This package quantitates and calculates the dimensions of arterial segments, as well as those of the left ventricle of the heart, imaged during x-ray-based cardiac catheterization. The software runs on Windows 2000 and Windows XP operating systems for PCs featuring a Sectra IDS5 Radiology Workstation.

Exemplifying the versatility of image management products cleared by the FDA in March is Mirada's RTist multimodality workstation software, which can serve as a stand-alone PACS or an adjunct to existing image processing systems. RTist processes anatomical as well as functional images, registering and fusing them. It incorporates standard visualization, as well as volumetric features. Volume and linear measurement functions support the evaluation and quantification of tumor measurements, location/displacement study, and analysis and evaluation of hard and soft tissues. The software also supports interactive segmentation of the region of interest, automated contouring of multislice regions of interest, and labeling of "avoidance" structures in preparation for invasive procedures.

Instatrak with Multiple Dataset Navigation is an upgrade of GE Healthcare's interactive image-guided surgical system. The upgrade provides the added functionality of fusing data sets from two modalities. Navigation is then possible on the basis of combined CT and MR data, for example, with the secondary or registered data sets acting as a visualization enhancement for surgical planning and intraoperative guidance.