FDA reviewers set two-year high as RSNA meeting looms

Clearance of radiology devices boom in October

Not in a long time has the radiology industry fared so well with FDA reviewers as it did in October. In that month, the agency cleared 40 radiology devices. Over the past two years, the highest number of clearances was 30--once in October 2000 and again in December 2001.

October made it three months in a row that radiology had bigger than average clearance numbers, as September accounted for 25 and August for 27. The leading technology segments were image management and x-ray, with 10 submissions each receiving positive reviews, although one of x-ray clearances was for a dental system. Radiation therapy accounted for eight, MR for six (of which four were coils), and CT, nuclear medicine, and ultrasound each had two.

In MR, Toshiba and Hitachi each logged one clearance. Toshiba boosted the gradients on its midfield open Opart, creating a high-performance version called the Opart Ultra, which is further bolstered by modified sequences that support faster data acquisition. Hitachi received clearance for a software upgrade to its 0.7T Altaire. Three of the four coils that cleared are made by MRI Devices, the fourth by USA Instruments.

X-ray standouts include the MultiDiagnost Eleva, a multifunctional system designed for radio-frequency diagnostic and interventional vascular procedures. Eleva features a tilting C-arm, a floor-mounted stand, and an integrated tilting patient support table. The table is supported at only one end, allowing patient access from both sides. The system comes with a 38-cm multimode image intensifier, XTV imaging system, collimator with laser cross for patient positioning without x-rays, Philips glass or metal x-ray tube, and TV monitors. Under a separate submission, Philips obtained clearance for an option to the Eleva system. Called Philips Digital Imaging option release 1, this separate device is an image processing subsystem that consists of digital imaging hardware and software. It receives digital images from the CCD camera in the Diagnost Eleva system.

Innova S is essentially an Innova 2000 flat-panel cardiac cath system outfitted with optional features including a C-arm that permits rotational cardiac angiography along a 200º arc at variable speeds from 20º to 40º per second. The rotational capability was shown for the first time at the American Heart Association meeting Nov. 17 under the trade name InnovaTrace.

Also in this category is the Canon CXDI-11 LANMIX MLT, an upgraded version of the company's existing flat-panel digital x-ray product. This latest version includes software that allows "multi-objective frequency processing," according to the FDA.

In CT, GE obtained clearance for its e-Speed, a high-end cardiology system commercially launched at the AHA meeting. The underlying technology was developed initially by Imatron, which was acquired last year by GE. Data provided to the FDA describe e-Speed as an angiographic x-ray system and whole-body CT scanner that uses electron beam technology, a modernized beam control system and redesigned x-ray data acquisition system, a higher power HV supply (compared to the previous EBT system), an operator console, and the capability to scan at 0.05 sec as the primary mode of operation. Positioned primarily to be sold for cardiology applications, e-Speed has been cleared by the FDA for a range of other uses, including vascular, lung, and colon evaluation.

In nuclear medicine, a modification of Siemens' e.cam computer/e.soft workstation cleared the FDA. The modification provides attenuation correction, improved reconstruction, PET quantification, and HIPAA (patient privacy) support.