FDA action breaks regulatory gridlockPatience is a virtue, especially for medical imaging companieswith new products stuck in the review process at the Food andDrug Administration. Acoustic Imaging of Phoenix was one suchcompany. The ultrasound
Patience is a virtue, especially for medical imaging companieswith new products stuck in the review process at the Food andDrug Administration. Acoustic Imaging of Phoenix was one suchcompany. The ultrasound vendor found its patience sorely testedas its 510(k) application for a 3-D ultrasound workstation languishedat the FDA for nearly two and a half years.
This story has a happy ending, however. Acoustic Imaging announcedlast week that the FDA has cleared its 3-D Ultrasound ImagingWorkstation. AI is believed to be the first company with a 3-Dultrasound reconstruction product on the market. Cone Instrumentsof Solon, OH, and Tomographic Technologies of El Toro, CA, arestill waiting for FDA clearance for their products.
Acoustic Imaging unveiled the workstation at the 1991 RadiologicalSociety of North America meeting and began placing the systemin beta sites shortly thereafter (SCAN 10/21/92). AI filed a 510(k)application with the FDA in July of 1992.
The workstation uses a 3-D probe with a stepping motor thatmoves the transducer in increments to acquire 2-D slices. Theslices are converted to digital form by a video frame-grabberand transferred to the workstation. The workstation runs on dualmicroprocessors, an Intel 486 chip for basic tasks and an IntelI860 for 3-D rendering.
Acoustic Imaging is continuing to work with luminary sitesto monitor performance and develop clinical applications for theworkstation. The company said that users at its clinical sitesbelieve the workstation could prove useful in obstetrical, prostateand breast imaging. AI will adopt a conservative tack in distributingits new technology: The vendor plans to focus on shipping theworkstation to selected research sites, rather than making a blockbusterproduct introduction.