MRI and diagnostic ultrasound dominate the latest batch of imaging-related devices cleared by the FDA. These modalities accounted for half of the 26 products cleared for marketing in the U.S. Radiation therapy equipment came in third with five products,
MRI and diagnostic ultrasound dominate the latest batch of imaging-related devices cleared by the FDA. These modalities accounted for half of the 26 products cleared for marketing in the U.S. Radiation therapy equipment came in third with five products, and the remaining approvals were scattered among CT, x-ray, and image management.
The Logiq 9, a general-purpose diagnostic ultrasound product developed by GE Medical Systems, cleared May 18. The company cited its Logiq 700 as a substantially equivalent predicate. The specifications of the new product indicate a wide range of applications: fetal and obstetric, abdominal, pediatric, small parts, cardiac, peripheral vascular, and musculoskeletal. A battery of 13 transducers allows the device to do transesophageal, transrectal, transvaginal, and intraoperative imaging that includes abdominal, thoracic/cardiac, vascular, and neurological exams.
The system offers substantially improved ergonomics, operation, maneuvering, and ease of use. The mobile console measures 65 cm wide, 96 cm deep, and 144 cm high, and the user interface includes a computer keyboard and specialized controls in concert with a color video CRT. Data are digitally acquired, processed, and displayed.
Philips ATL was given the go-ahead May 4 to begin marketing the HDI 5000 with assisted border detection (ABD), XRES imaging, and panoramic measurement capability. The company cited Agilent’s Sonos 5500 digital acoustic quantification feature as basically equivalent to its ABD, which provides a semiautomated technique for calculating left ventricular volume and ejection fraction of the heart. Philips’ goal with ABD is to improve throughput by simplifying the steps required to outline the left ventricular cavity. The user has the option of accepting the automated trace and selected image frames or manually modifying the traces to allow proper alignment. The SieScape feature on Siemens’ Elegra system was cited as the predicate device for ATL’s panoramic measurement capability, which allows the user to perform distance or area measurements using tools already available on the HDI 5000. XRES imaging, which is similar to image processing filters already on the HDI 5000, enhances gray-scale image quality by reducing speckle and noise and clarifying tissue margins and boundaries. This feature will operate in real-time and after acquisitions, during review of the multiframe cineloop image onboard the HDI 5000.
MRI may be increasingly used in women’s healthcare with clearance of the Siemens MR breast biopsy device. The optional accessory, which is compatible with Siemens’ Magnetom MR scanners, is designed to provide images while allowing access to the breast for biopsy. The FDA agreed with Siemens’ assertion that the new device is substantially equivalent to the Philips stereotactic localization device. Prior to the FDA decision regarding the Siemens product, which was rendered May 30, Philips had the only commercially available MR biopsy device. In the November issue of Medica Mundi, a Philips-sponsored journal, physicians at the University of Bonn radiology department reported the use of Philips’ device to perform MR-guided wire localization on 202 lesions in 170 patients. Lesions were successfully removed in 194 of the 202 cases (97%).
Israel-based UltraGuide took a different tack on MRI guidance with the development of its MR-Guide 3000, which was cleared May 24, just two weeks after the 510(k) application was submitted. (The device was reviewed by a third party.) The frameless stereotactic device displays graphics that show the position and future path of a rigid interventional instrument, such as a biopsy or aspiration needle. Graphics appear on a computer monitor in the context of MR images of target organs. The system also allows the medical team to monitor patient respiration. Predicate devices cited were the Medtronics StealthStation and CT-Guide 1010. The MR-Guide 3000 uses an optical tracking system made up of an infrared light source that illuminates retroreflective targets so as to track the location and orientation of the interventional instrument. The tracking information is transmitted to a data processor, which merges the graphic overlay of the interventional instrument and the MR images.