The radiology pipeline was anything but encouraging in July, as the FDA cleared only 21 products. This was the second consecutive month that the number of 510(k) clearances dipped to around 20 (SCAN 8/8/01). Last year, the monthly numbers were in
The radiology pipeline was anything but encouraging in July, as the FDA cleared only 21 products. This was the second consecutive month that the number of 510(k) clearances dipped to around 20 (SCAN 8/8/01). Last year, the monthly numbers were in the high 20s throughout the summer, dipping to 21 in September, then rocketing back to near 30 in both October and November, as vendors prepared for the RSNA meeting. The slim pickings this summer may not affect new RSNA product releases if FDA activity picks up in the next few months. But reasons for concern involve more than just the low numbers.
The types of products being cleared do not represent the glamour modalities, which have fed industry growth over the last several years. Only one CT product cleared the FDA, and it appears to be an enhanced version of a previous model. The only MRI product among the July offerings was an enhancement. The sole ultrasound product was a handheld unit, although its development may signal a rising level of performance in this category. Teratech’s model 2000 features Doppler and harmonic imaging modes with transducer frequencies ranging up to 8 MHz, delivering frame rates up to 58 per second. Images are presented on a 15.7-inch liquid crystal display, an unusually large area for handheld products. The company cited the Acuson Sequoia and Aspen as substantially equivalent systems.
Radiotherapy products were the most popular of the July clearances, accounting for 45% of the group. Radiotherapy clearances included two turnkey radiation delivery systems. Image management products were close behind with 29%, which were mostly software packages designed to evaluate 2-D or 3-D images.
Two proton beam products, classified by the FDA as charged-particle radiation therapy systems, were cleared. Massachusetts General Hospital won FDA acceptance July 20 for its Northeast Proton Therapy Center. NPTC is designed to treat patients with localized tumors or other diseases susceptible to radiation treatment. The product, described by the hospital as a “facility,” produces and delivers a proton beam of known energy, intensity, and shape. It creates and directs the proton beam, produces a transverse and longitudinal dose distribution, and delivers the designated dose. The facility was judged substantially equivalent in function, character, and accessories to proton facilities operating at Harvard University and Loma Linda University.
Eight days earlier, Belgian firm Ion Beam Applications won FDA clearance for its Proton Therapy System. As with MGH, the Belgian firm cited the Loma Linda and Harvard devices as predicates for its system, noting that PTS is designed to treat patients with localized tumors and other radiosensitive conditions. PTS, like other such devices, may be configured to work with several rooms.
The other category, x-ray, featured a digital product, Smart Rad, developed by Israeli firm CMT Medical Technologies. The system uses the Pixium 4600, a flat panel manufactured by Trixell, a joint venture involving Siemens Medical Solutions, Philips Medical Systems, and Thomson Tubes Electroniques. The amorphous silicon-based solid-state detector is the cornerstone of Philips’ Bucky-Vision and Siemens’ Thorax FD and Multix FD. The Trixell detector has also been incorporated into Infimed’s StingRay digital upgrade for existing conventional radiography systems. Smart Rad will also likely be sold as an upgrade. Documents filed with the FDA indicate that the product will not include the x-ray system. Smart Rad will, however, ultimately be configured with the flat panel mounted in a bucky interfaced with the x-ray system, workstation, monitor, and laser imager. It will be used wherever conventional film-based systems are used for general radiography exams except fluoroscopy, angiography, and mammography.
Following are FDA-provided data on the other July clearances.