Industry enters regulatory doldrums as FDA clearances dip in September

A lull enveloped September, as FDA reviewers cleared just 25 new radiological devices - a slight dip from August and well below the earlier summer months, which rode into the high 30s. The industry was still well ahead of last year, however, in the total number of devices cleared for marketing in the U.S.

Most September clearances - eight - were in image management. Ultrasound trailed with six. X-ray and radiotherapy each had three; nuclear medicine and CT had two; MR had one.

Half the image management products were PACS. Stentor's iSite PACS is designed for use with general-purpose computing hardware to acquire, transmit, process, and store images and data throughout a clinical environment. Stentor explicitly disallowed the presentation of lossy compressed mammographic images and digitized screen-film images. Yet the new product is a big step up from the company's iSite Radiology workstation, a software-based product cleared by the FDA three years ago.

Also notable was Emageon's client-server software package, Ultravisual. The PACS software features an upgrade from previous iterations to allow the display of digital mammograms.

Siemens obtained clearance to market its Leonardo syngo Cardiology Workstation. The new product, which is based on Windows XP, offers a comprehensive cardiology solution to view, optimize, and postprocess digital cardiological, as well as radiological, images. The product will be available as a software-only solution for the end-user or as a complete workstation including hardware and software.

Hitachi won FDA clearance to market its SceptreP3 PET/CT scanner. The system, shown as a work-in-progress at the Society of Nuclear Medicine meeting in June, combines an LSO (lutetium oxyorthosilicate)-based rotational PET scanner with a quadslice CT. The partial-ring PET detector is supplied by CPS of Knoxville, TN. The company was planning to release the system in the fourth quarter, pending a positive FDA review (SCAN 7/16/04). CT data are used to create attenuation correction maps for the PET images as well as diagnostic anatomic images. Its computer workstation, called Avia, initiates data acquisition and processes the images. The workstation, which is provided by CPS subsidiary Mirada, can fuse CT and PET images into one display.

GE Healthcare was cleared to begin marketing a new version of its Discovery ST PET/CT system. The enhanced configuration includes an "alternate detector option," according to the FDA application. It is designed to generate head and whole-body attenuation-corrected PET images and integrated PET and CT images. Applications include evaluations addressing cancer, cardiovascular disease, and brain dysfunction. The device can also assist in radiotherapy planning.

Several new CT products stood out. Siemens' Somatom Spirit is a low-cost, compact, dual-slice scanner. The system, which will be unveiled at the RSNA meeting in November, is based on the Emotion Duo platform.

Philips' Brilliance CT Private Practice CV product was cleared in September. The system, which was unveiled late in the month at the Transcatheter Cardiovascular Therapeutics conference in Washington, DC, is restricted to the analysis of cardiac and peripheral vasculature. It cannot be used to perform radiologic exams (SCAN 9/29/04). As the name implies, the 16-slice scanner is being aimed at cardiologists in private practice.

Siemens can now begin marketing a radiation treatment planning (RTP) package designed for use on standard CT scanners. The package is intended to assist in preparing geometric and anatomic data needed for external-beam radiotherapy treatment planning. RTP requires higher geometric accuracy from anatomic data than is usually obtained on diagnostic CTs. The RTP package enhances the capability of Emotion CTs by improving gantry tilt accuracy, reducing tabletop deflection, providing externally adjustable gantry laser lights, increasing tube positioning accuracy, simplifying horizontal positioning of the table, and optimizing field coverage using extended field-of-view.

Elekta Instrument of Stockholm gained clearance for its Leksell GammaPlan 4C with MultiView. The computer-based dose-planning system, designed specifically for use with the Leksell Gamma Knife, adds support for brain atlas structures and the visualization of color-mapped PET images for use in preoperative planning. It also coregisters frameless images with those taken stereotactically, thereby simplifying stereotactic radiosurgery procedures.