Volume drops to lowest point in two years March was not a good month for FDA clearances, as the number of products passing regulatory review dropped to just 17. This marked the fewest products cleared by the agency since January
Volume drops to lowest point in two years
March was not a good month for FDA clearances, as the number of products passing regulatory review dropped to just 17. This marked the fewest products cleared by the agency since January 2000. Radiation therapy accounted for the most with five clearances. X-ray had four; CT, MR, and image management each had two. Nuclear medicine and ultrasound had one each.
The paucity of newly marketable devices, however, did not reflect the nature of the products coming out of industry's pipeline. Several were particularly noteworthy, including Philips' Integris Allura 9, a flat-detector angiography system unveiled March 17 at the annual meeting of the American College of Cardiology (SCAN 3/20/02).The Allura was cleared by the FDA two days before the start of the meeting.
Hitachi Medical Systems America has been cleared to sell Pronto, a CT scanner featuring "third generation" geometry with x-ray tube and x-ray detector mounted on a rotating frame. The system features a solid-state x-ray detector. No mention is made of slice capability, but the 510(k) summary cites the Philips Secura as a predicate device in materials, technology, and functional methodology. Hitachi had been a long-time partner of Philips in CT and is believed to have worked on the development of Secura. When Philips purchased Marconi Medical, Philips strategists decided to phase out the Secura CT, a single-slice scanner unveiled at the 2000 RSNA meeting. The scanner was originally positioned as a platform on which the Philips multislice detector would be mounted (SCAN 12/26/01).
GE received clearance in March to market its CardIQ Analysis II package, a postprocessing software option designed to analyze CT angiography images. The package displays structures of the heart in a maximum intensity projection, reformat, or volume rendered view. It can measure the diameter of the vessel, Hounsfield units within coronary arteries, or plaque density within a vessel. CardIQ Analysis II runs on the Advantage Windows Workstation.
Siemens obtained market clearance for its modified Magnetom Rhapsody system. The company initially gained FDA clearance for Rhapsody Jan. 23, 2001. The 510(k) summary indicates no differences between the initial application and this one except for a "modified SAFE Model." The modification removes a patient safety constraint regarding the power that can be applied to the gradient, according to a Siemens spokesperson. The safety constraint was eliminated after tests conducted by Siemens demonstrated that its removal would not harm patients.
Viatronix of Stony Brook, NY, gained clearance for its V3D Colon, a system for the display and visualization of 3D and 2D DICOM images obtained using CT and MR scans. The product is designed for patient screening and detection of polyps, masses, cancers, and other lesions. Views include inner- and outer-surface 3D volume renderings, as well as orthogonal and multiplanar reformatted 2D images. Users can navigate freely within regions of interest or follow automatically computed paths to fly through or around the outside of the colon.
Boulder, CO-based Nuclear Cardiology Systems obtained clearance to sell its NeuroSpect Quad gamma camera. The four-headed system is designed specifically to detect the location and distribution of radionuclides in the brain. The device includes accessories such as signal analysis and display equipment. Its development falls outside the traditional turf of NC Systems, which has focused on cardiology throughout its 20-year history.