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
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.
GE also received clearance Aug. 7 for the CT Colonography/Navigator2 software package, which generates CT-based images of the inside, wall, and outside of the colon. The goal is to detect colonic lesions. CT Colonography works in concert with Navigator2, an advanced visualization software that provides endoluminal views. Navigator2 will be used to investigate polyps, tumors, and other structures within the anatomy.
The FDA cleared three new x-ray systems in August. The Easy Moving Mobile X-ray Unit, Model SM-HF, by Sedecal USA, passed Aug. 31. It is designed to examine all body parts, including the skull, spine, chest, and abdomen. The mobile unit, which can plug into the wall or run on batteries, is described by Sedecal as compact and quick to set up and operate. It is composed of a base unit housing the high-voltage generator, controls, and a turnable arm with rotating tube head. Adult and pediatric patients can be imaged standing, sitting, or lying down.
The ISI-2500 mobile C-arm from Imaging Services provides fluoroscopy during diagnostic and surgical procedures. The system, which cleared the FDA Aug. 23, may be used for gastrointestinal, urologic, orthopedic, neurologic, vascular, and emergency room procedures. The C-arm, which is made by Korean supplier Medison, has been sold into markets outside the U.S., including Asia and Latin America. The company describes the ISI-2500 as a high-end, low-cost C-arm equivalent mechanically and electrically to the GE OEC Medical Systems 9600 mobile C-arm. The key difference between the two products, according to Imaging Services, is the imaging chain.
Trex Enterprises of San Diego received FDA clearance to market its PDX-2000 portable digital x-ray system. The new product, which passed FDA review Aug. 16, consists of CXDI-22 retrofit, an amorphous silicon-based sensor generally available from Canon, a MinXray Portable Source Generator, and proprietary adaptations developed by Trex. The system supports general radiographic procedures.
Radiation therapy clearances were typical of past months, with four of the five clearances involving brachytherapy or enhancements to existing systems. The one exception was CyberKnife, an image-guided, stereotactic radiosurgery system from Accuray of Sunnyvale, CA, which passed the FDA Aug. 10. CyberKnife combines planning, imaging, and treatment subsystems. The treatment planning component can process CT and MR data sets into 3-D models. Diseased and surrounding healthy tissue is rendered in the context of reference markers known as fiducials that allow the patient to be properly oriented for treatment. This component also calculates dosage. The imaging system delivers real-time, orthogonal x-ray images of the patient to verify treatment position and alignment by tracking the skull and fiducials in 3-D space. These data are then compared with the 3-D model to ensure accurate pointing of the 6-Mv linear accelerator. The planning system can handle up to 300 CT slices and fuse these data with those from MR.
In diagnostic ultrasound, Aloka has been cleared to market two new products. The SSD-5000, cleared Aug. 29, is a variation of the company’s SSD-5500. The new system may be fitted with any of 23 different transducers. The SSD-1000, cleared Aug. 30, is similar to the SSD-1400. The new product can be configured with up to 18 transducers.
Following are FDA-provided data on the other August clearances.