FDA clearances stabilize in low 20s with April reviews

Chinese midfield MR, Siemens 3D software star

The number of devices passing FDA review in April was encouraging, but the devices themselves were mostly unremarkable. The list was dominated by relatively simple image management solutions, brachytherapy products, and MR coils, and some ultrasound and PACS iterations.

Standouts among the 21 devices cleared through the FDA's 510(k) process in April were a 0.35T MR scanner from Chinese OEM Neusoft and a 3D colonography system from Siemens. Another was the Titan ultrasound scanner from SonoSite, which offers the mobility of a handheld system and much of the versatility found in cart-based systems (SCAN 4/30/02). Rating some attention were two ultrasound systems (one dedicated to transcranial imaging, the other an upgrade to GE's Logiq 9), an MR coil from GE, a PACS advance from PointDx, and a dry printer from Codonics.

The number of devices compared well with recent months' output by FDA reviewers (24 in March and 21 in February) as well as historically (23 in April last year, 26 in April 2001, and 24 in April 2000). Nine of the cleared devices were clustered in image management. Five were in radiotherapy, three each in ultrasound and MR, and one in nuclear medicine.

The Superopen 0.35T MR scanner is apparently similar to Hitachi's Airis II, according to its developer, Neusoft Digital Medical System of Shenyang. In its FDA submission, the firm claimed the software onboard the Superopen was comparable to Airis II Version 4.1.

Common features of the two products include open permanent magnets and standard gradient and radio-frequency subsystems. Image reconstruction on the Superopen is controlled by the console computer through an interactive user interface. The system produces 2D and 3D images that can be filmed or electronically stored.

The Superopen, a midfield scanner, is the latest addition to a comprehensive line of imaging products developed over the last five years by the Chinese company, which is preparing to make a concerted effort to win sales beyond its home turf (SCAN 5/14/03).

The other two MR devices to clear were coils. The 3T general-purpose flex coil from GE Medical Systems is a modification of the company's existing 1.5T general-purpose flex coil. The higher field strength of the new device is the primary difference between the two. The new coil, which will be offered as an option on the GE Sigma 3.0T whole-body MR scanner, is designed to facilitate imaging of the brachial plexus, hip, and thigh, as well as allow dynamic imaging of the knee and ankle. It consists of two 5 x 6.5-inch surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy. This flexibility, according to GE, allows the coil to be applied to a wider range of patients than if it were rigid.

Siemens Medical Solutions passed FDA muster with its Syngo colonography package, a self-contained image analysis package for evaluating CT data sets obtained using Siemens' Somatom Emotion and Sensation CTs. This virtual colonography product combines image-processing algorithms that provide 3D intra- and extraluminal views of the colon with workflow and reporting tools. An evaluation tool allows volumetric analysis of colonic polyps or lesions over time to help assess changes in growth. It can also help classify conspicuous regions of tissue with respect to size, dimensions, shape, and position.

PointDx won clearance for Rex 3.0, the company's latest post-processing software for CT and MR data. The package, which runs on a PC, allows 3D volume rendering and virtual endoscopy, and it supports report generation. This latest iteration builds on Rex 1.0 to allow the processing and display of MR images and the use of two monitors, one for viewing images, the other for viewing reports.

Codonics got the go-ahead from the FDA to start marketing its EP-1000 medical color dry imagers. The product line is based on dye-diffusion technology, which generates continuous tone, diagnostic quality black-and-white and color images on reflective, incident-light-viewed media.

Ultrasound clearances included a pulsed Doppler imaging system from the Nicolet Vascular division of Viasys Healthcare. The system is designed for transcranial imaging of adult patients and for peripheral vascular work. The FDA also cleared an improved version of GE's Logiq 9, which has the same physical design and applications as the current model.