BioArray Solutions (Warren, New Jersey), a molecular diagnostics company, reported the FDA 510(k) clearance of a new immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens (ENA). The ENA IgG BeadChip Test System, for use on the company's Array Imaging System (AIS 400), uses BioArray Solutions' BeadChip format to simultaneously detect multiple analytes of interest on a tiny silicon chip holding a planar array of color-encoded microparticles. The AIS 400 fully automates image acquisition and integrated analysis to rapidly generate assay results.
CompuMed (Los Angeles), a medical informatics company serving the healthcare community with diagnostic software solutions, said it presented at the recent Society for Computer Applications in Radiology meeting in Orlando, Florida, results of a clinical study comparing its digital S-ray OsteoGram against its standard film S-ray OsteoGram. The results affirm that the digital version assesses Bone Mineral Density (BMD) more efficiently than the standard X-ray version, with comparable reliability and image quality. The study's DICOM BMD results were found to correlate highly with the standard film-based system, which has been used successfully for nearly 10 years to diagnose osteoporosis for more than 140,000 patients worldwide. Over that time, the film-based OsteoGram has developed a reputation as an accurate, low-cost bone density test. The newer DICOM OsteoGram uses a digital image derived from filmless X-ray equipment to enable clinicians to perform accurate and precise osteoporosis testing. As a result, the DICOM OsteoGram can provide a similar result as a standard X-ray, but more quickly and at a lower cost.
Edap TMS (Lyons, France) said its Ablatherm-HIFU, a non-invasive technique using high intensity focused ultrasound in prostate cancer patients, is now available in North America for the first time at the Don Mills Surgical Unit (Toronto). Ablatherm-HIFU delivers a beam of high intensity focused ultrasound to the prostate. Under spinal anesthesia, the Ablatherm-HIFU probe is placed into the rectum through which the focused ultrasound waves are directed into the cancerous prostate tissue without damage to the intervening tissue. This causes a rapid rise in temperature inside the prostate cells to 85 degrees Celsius, destroying the cancerous cells. The procedure is completed in less than three hours without blood loss or exposure to radiation. EDAP TMS and Maple Leaf HIFU Co. have entered into an exclusive sales agreement allowing Maple Leaf to market the Ablatherm in Canada and to develop access to Ablatherm-HIFU technology throughout the Canadian territory.
GE Healthcare (Waukesha, Wisconsin) reported launch of its new family of LightSpeed computed tomography systems that now include exclusive Volara digital Data Acquisition System (DAS), and the Xtream FX workflow platform. The rollout was made at the 7th Annual International Symposium on Multidetector-Row CT (MRCT), presented by the department of radiology at the Stanford University School of Medicine. The LightSpeed VFX Series will utilize the Volara digital DAS technology and Xtream FX workflow platform, developed for GE's LightSpeed VCT. The company said that, with these instruments, "clinicians will be able to tap many of the unprecedented images quality and productivity capabilities of the LightSpeed VCT on GE's 4, 8 and 16 slice CT systems." Included in the LightSpeed VFX series is the Wide Open Workflow with Xtream* FX, the second generation of Xtream workflow technology, enabling imaging departments, GE said, "the ability to keep pace with the large volume of data generated by MDCT systems."
IRIS International (Chatsworth, California), a manufacturer of automated IVD urinalysis systems and medical devices, said its StatSpin (Norwood, Massachusetts) subsidiary has initiated shipments of its new next-generation centrifuge, the StatSpin Express 3. The Express 3 has a larger capacity than the Express 2 model and represents a new platform for StatSpin enabling further application expansion in urine, blood and body fluids. Statspin Express 3 addresses critical workflow needs by providing rapid sample processing of serum or plasma. The Express 3 can separate blood in only two minutes compared with traditional centrifuges that take 10 minutes or more.
Swissray International (Elizabeth, New Jersey) reported that it has received FDA 510(K) clearance to market its newest direct digital radiographic system, the ddRCombi Trauma. The ddRCombi Trauma is engineered to provide fast, high-quality digital imaging in the emergency department or trauma center. With this system, traumatized patients can be easily imaged from head to toe without being moved. The ddRCombi Trauma features a fixed table with elevating base, four-way floating top, and automatic positioning of the detector for cross-table imaging with the push of a single button on a wireless hand-held remote control. The tabletop easily slides away for access to the digital detector for wheelchair and upright exams. The system includes the eXpert4000 control and communication center. A memory function enables fully programmable user functions, including automatic positioning for every body part as well as from existing images on SwissVision. It is fully remote monitoring capable.