Industry closes 2005 in FDA slump

March 20, 2006

The FDA was good to the radiology industry in 2005. For the third time in as many years -- and the fourth in the last five -- the regulatory agency cleared more than 300 radiological products. The last quarter could have been better, however.

The FDA was good to the radiology industry in 2005. For the third time in as many years - and the fourth in the last five - the regulatory agency cleared more than 300 radiological products. The last quarter could have been better, however.

A slump in each of the last three months caused the industry to finish behind each of the previous two years in the total number of 510(k) clearances. Vendors in 2005 ushered 314 devices through the premarket notification process, 35 short of the record number the previous year and 25 short of 2003's total.

October had just 26 radiology clearances, compared with 36 in the previous year's period. November had 34 compared with 42 in 2004. December scored 22, two less than December 2004.

The slide appears to be continuing, as the industry has gotten off to a rocky start in 2006. January saw 21 devices clear the regulatory agency, nearly double the 12 clearances the year before, but well behind the 29 in January 2003 and 25 in that month of 2002. Preliminary numbers increase concern for February. Early postings on the FDA Web site indicate that just 15 radiological products got the green light last month compared with more than 20 in February of each of the last five years. (Documents providing details about clearances are usually posted on the FDA Web site by the middle of the following month.)

Several of the recent regulatory graduates were highlighted at the RSNA meeting. These include Siemens' Expert-i, which allows distant operators to take control of the system or observe real-time results on their PCs while patients are being scanned. Another is IDX's ImageCast, which GE has now adopted as its Centricity PACS platform following the company's January acquisition of IDX. A more recently showcased product to have made it through the FDA clearance process is Philips' time-of-flight PET/CT scanner, Gemini TF, which was introduced at the European Congress of Radiology in early March.

Still to appear on the commercial stage are several January clearances. The ScanMate Mobile CT System, developed by Analogic and its partner Schaerer Mayfield USA of Cincinnati, is a mobile CT scanner featuring a lightweight gantry and a 384-element solid-state detector array. Medison has received FDA clearance for two general-purpose sonography systems: Sonoace X4 and Accuvix V7. Both feature conventional imaging modes including power Doppler, harmonic imaging, and 3D.