FDA clearances for radiological devices dip in May

June 27, 2005

Vendors managed to clear just 21 radiological devices through the FDA in May, one fewer than April. Most of the cleared devices were relatively simple. Several addressed dental imaging or low-level image management.

Vendors managed to clear just 21 radiological devices through the FDA in May, one fewer than April. Most of the cleared devices were relatively simple. Several addressed dental imaging or low-level image management.

The majority were spread evenly over three modalities: six in radiotherapy and five each in x-ray and ultrasound. Three involved image management, and two had applications in nuclear medicine. The latter two appeared at the Society of Nuclear Medicine meeting held June 18 to 22 in Toronto.

GE's ViewPoint was one of the nuclear medicine clearances. The software-based medical image management system was showcased at the GE booth at the SNM meeting as a productivity tool that simplifies the assessment of nuclear medicine images. The FDA filing cited the ability of the software to support patient scheduling, review exam images and data, and prepare and print reports. Although the technology appeared at GE's nuclear medicine booth in Toronto, it is not confined to this modality alone. In its FDA submission, the company specifically cited the product's ability to communicate with ultrasound scanners and other PACS devices.

A 64-slice version of Philips' Gemini GXL popped up in conversation with company executives at the SNM meeting several weeks after a 64-slice CT option passed FDA review. The PET/CT, cleared for whole-body, head, heart, and other organ imaging, is scheduled for routine commercialization in the first half of 2006. It is specifically tasked for, but not limited to, the evaluation, detection, and diagnosis of cancer, cardiovascular disease, and neurological disorders; detection, localization, and staging of tumors and diagnosis of cancer patients; and support of treatment planning and interventional procedures.

Philips executives talked up the appeal of the system for cardiological applications. Their FDA submission noted that the cardiac imaging software quantifies cardiology images and data sets, including myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. PET and CT subsystems can be operated in concert or independently.

An upgrade of Siemens' Sequoia stood out among ultrasound devices clearing the FDA. The sonographic flagship has been enhanced to provide real-time 3D imaging, although the FDA filing notes that Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum or as color-coded 2D images. The system can acquire harmonic echo data and display them in B- and M-mode, pulsed- and continuous-wave Doppler, color and power Doppler, a combination of these modes, harmonic imaging, and real-time 3D imaging.

Breakaway Imaging of Littleton, MA, won clearance for a mobile digital fluoroscopy product, called the O-Arm imaging system. The company compared the product in its FDA filing to Siemens' Siremobil ISO-C in clinical capability. Both generate 2D fluoro and 3D image sets and are designed to support intraoperative applications.

The O-arm is physically distinguished, however, in that imaging chain components are mounted on a C-shaped rotor inside an enclosed, full-circle housing. This housing opens to allow the patient to be positioned inside. The rotor completes a 360° circle inside the housing when scanning the patient. The system uses a rectangular flat-panel digital detector.