FDA clearances rebounded sharply in August, tying the year-high number of 29 reached six months earlier. The sharp increase contrasted starkly with two months of very low numbers—20 in June and 21 in July. The reason for those poor showings may have become clear.
The August clearances include six products submitted in April or May. The submission dates indicate clearly that FDA reviewers took longer than the usual 90 days to examine these 510(k) submissions. If these reviews had been conducted in the prescribed time, the number of June and July clearances would have been in the mid 20s, typically the number reviewed and cleared by the FDA.
Three product types were affected by the delays. Two of the five clearances in radiation therapy were submitted in April. Two of the eight x-ray-related clearances were submitted in March. And two of the five ultrasound submissions were submitted in March, both involving Aloka products.
Cleared products represented five different types of radiologic equipment. X-ray systems had the largest number of clearances, barely edging out MR, eight products to seven. Ultrasound and radiation therapy each accounted for five clearances. CT and image management each had two.
MR clearances were composed of mostly minor offerings, namely coils or enhancements to existing systems. An exception was the Aug. 3 clearance of the GE Signa 1.5-tesla TwinSpeed scanner. TwinSpeed combines gradients from the Signa Horizon Cx and the Signa CVMR (cardiovascular) scanner. The product has the same basic technological characteristics as these two other devices and the same basic design, construction, and materials. The company has already begun installing these scanners at clinical sites (SCAN 9/5/01).
Another standout is GE’s PROSE (PRostate Spectroscopy and imaging Exam), an image-guided MR clinical assessment and spectroscopy package. PROSE, which cleared the FDA Aug. 22, acquires high-resolution anatomical images and volume-localized hydrogen spectra of the prostate. The option uses one or more sets of localizer images to determine the size and location of the spectroscopic volume. Data are acquired using an endorectal probe outfitted with phased-array coils. The relative concentrations of metabolites recorded using PROSE may indicate prostate disease. The new product is a version of the PRESS (Point RESolved Spectroscopy) double-spin-echo pulse sequence.
The two FDA-cleared CT products are noteworthy. GE’s HiSpeed X/i Smart Gantry Option CT scanner is built around a gantry mounted on a dolly. The gantry, rather than the patient table, moves during the examination. The system, which cleared the FDA Aug. 10, is not designed as a diagnostic scanner. Rather, the product is to be used in conjunction with a linear accelerator. GE did not ask the FDA to review any claims outside CT scanning, but the apparent purpose of the system is radiation therapy. The modified product uses the same solid-state detector and x-ray tube integrated with GE’s existing family of HiSpeed CT scanners.
