FDA clearances in June signal subpar performance by industry

August 15, 2005

Efforts by the imaging industry to clear radiological devices have slipped into a narrow corridor of moderate success, as companies in June scored just 23 FDA clearances, two more than the previous month and one more than April. The pace of clearances now has drifted far below the level that led to last year’s record number of cleared products, which saw April 2004 with 36, May with 26, and June with 38.

Efforts by the imaging industry to clear radiological devices have slipped into a narrow corridor of moderate success, as companies in June scored just 23 FDA clearances, two more than the previous month and one more than April. The pace of clearances now has drifted far below the level that led to last year's record number of cleared products, which saw April 2004 with 36, May with 26, and June with 38.

This year's lackluster performance puts the industry on a pace reminiscent of 2001 and 2002, when it failed to crack the 300 level in clearances. Any hope for a boost from this glide path will have to wait until later this summer. Preliminary numbers from the FDA indicate that agency reviewers passed only 24 radiological devices in July, far below the 30 clearances recorded in July 2003 and the 36 achieved in July 2004.

The June 2005 clearances were spread over six modalities: image management with four PACS and two display monitors, ultrasound and x-ray with five each, MR and nuclear medicine three each, and radiotherapy with one. Three classes of products stood out: portable ultrasound, MR coils, and digital x-ray.

In the ultrasound category, Toshiba cleared its Famio SSA-530A. The mobile system employs a wide array of probes that includes flat-linear-array and convex-array transducers with a frequency range of approximately 3.75 MHz to 12 MHz. The general-purpose system can handle radiological and cardiological applications, including transrectal, transvaginal, and peripheral vascular imaging. A similar system from Toshiba, the Famio 5, is being sold in Europe.

Another general-purpose, compact ultrasound system, Esaote's MyLab 70, features tissue enhancement imaging and can handle phased, convex, and linear array, as well as Doppler probes. It is the latest in the MyLab series, which includes Model 30 CV and Model 50, both cardiovascular products. MyLab 70 is equipped with a CRT color display and DVD-RW disk drive. It can be linked to a PC via a LAN port.

Teratech is cleared to introduce two new versions of its Terason Model 2000 portable ultrasound system. The primary difference between the t3000 and Echo configurations is the ability to assess left ventricular dyssynchrony and to conduct tissue Doppler, which is available on the higher performance Echo. Both offer ECG triggering, as well as continuous wave Doppler.

New MR coils are typically less than spectacular, but the three that cleared the FDA in June promise to substantially extend the clinical range of advanced scanners. The Model CAC-127-8 Cardiac Array Coil, developed by Invivo, is designed for cardiovascular MR applications.

The open breast coil with biopsy plates from USA Instruments is a phased-array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements, from which the patient is insulated by a ridged plastic housing. The biopsy plate allows access to the breast anatomy during biopsy procedures. Biopsy needles are not included with the coil, which is designed for use with the 0.3T Aids-Elite MR scanner manufactured by Hitachi Medical Systems.

The 3T Prostate Imaging System from Medrad is a receive-only coil intended for high-resolution MR imaging and spectroscopy of the prostate and surrounding pelvic tissue. The coil is intended for use only with Siemens' 3T Trio.

In x-ray, Shimadzu earned FDA clearance for its DAR-7000 radiography system. The system, equipped with flat-panel sensor technology, is capable of generating chest radiographs. It was announced last November in Japan.

Siemens' Arcadis Avantic, a mobile x-ray system, relies on an image intensifier to operate in six different modes: digital radiography, fluoroscopy, pulsed fluoroscopy, digital cine mode, subtraction, and road mapping. The product was introduced at the European Congress of Radiology in March (DI SCAN 4/18/05).