• B-K Medical (Copenhagen, Denmark) reported the launch of its transrectal prostate transducer, the 8818, which combines simultaneous biplane and endfire transducers in one. The product uses simultaneous biplane imaging. enabling real-time simultaneous images of the prostate in both the sagittal and transverse planes. By seeing the prostate and biopsy needle in both planes at one time, users get direction to correctly target the intended sections and carry out their biopsy scheme precisely. Endfire imaging provides the view when taking biopsies in the apex of the prostate. The design of the endfire biopsy channel ensures the shortest distance to the apex, thereby helping users to avoid accidentally piercing surrounding tissue. B-K Medical, a subsidiary of Analogic, specializes in diagnostic ultrasound equipment.
• Ciphergen Biosystems (Fremont, California) said it presented data from a prospective clinical trial demonstrating that its ovarian triage test identified 84% of the ovarian cancer cases, compared to 33% identified using standard diagnosis methods without the test. Ciphergen said that, with its scientific collaborators, it has diagnostic programs in oncology/hematology, cardiology and women’s health with an initial focus in ovarian cancer.
• Masimo (Irvine, California) reported that an independent study demonstrated the superiority of its LNOP Blue Sensors in providing accurate, and continuous pulse oximetry readings in cyanotic infants with congenital heart disease. The Masimo LNOP Blue sensor — designed for use in pediatric patients with low oxygen saturation — was compared to a Nellcor OxiMax sensor and to a standard Masimo LNOP sensor not designed for cyanotic patients, and was shown to have a “significantly higher correlation to arterial blood gas in comparison to the two other sensors studied.”
• Rimage (Minneapolis) reported the launch of the Medical Disc System, featuring improvements to its patient CD and DICOM diagnostic study output and distribution. The disk system features three different hardware options, each containing an embedded processor, an integrated everest printer and a footprint for operation. The MDS 5100 is a compact design for patient CD and diagnostic study output. The MDS 5200 is for use with large and small PACS installations for Patient CD and diagnostic study distribution. The MDS 5300 is available with blue laser disc recorders, increased capacity, higher throughput, and the Rimage Publisher 7.4 software package for Patient CD and high-capacity DICOM Archive Discs. Rimage makes recordable CD, DVD and Blu-ray publishing systems.
• Roche Diagnostics (Pleasanton, California) reported that the FDA has accepted for review its applications for two human papillomavirus (HPV) tests. The Amplicor HPV test is designed to enable accurate detection of 13 of the more common high-risk HPV genotypes in standard clinical samples. The Linear Array HPV genotyping test is designed to identify which of the 13 high-risk HPV genotypes are present in a sample. Persistent infection with HPV is the principal cause of cervical cancer and its precursor, cervical intraepithelial neoplasia. Roche’s diagnostics division makes testing products and services to researchers, physicians, patients, hospitals and laboratories.
• Rosetta Biosoftware (Seattle) introduced the Rosetta Resolver gene expression data analysis system 7.0, with capabilities to promote standardized data storage and exchange. The system version 7.0 also provides support for endpoint data storage in the clinical data interchange standards consortium’s standard for exchange of non-clinical data format and additional gene expression platforms, such as the Illumina platform. The Resolver can accept and analyze data from a wide variety of expression profiling formats, and applies Rosetta Biosoftware’s proprietary error models to yield quality statistics for every gene expression measurement within the system. Rosetta is a provider of informatics software for life science research.
• Stereotaxis (St. Louis) reported initiating the HEAL HF clinical trial, designed to evaluate the ability to magnetically navigate to multiple potential pacing sites and then optimize LV lead placement to treat heart failure. The case included the evaluation of seven pacing sites in the left ventricle, which exhibited significant differences from site-to-site in the hemodynamic response of the patient’s heart, measuring cardiac function. The Stereotaxis magnetic guided lead placement system is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced X-ray exposure. Stereotaxis makes cardiology instrument control systems.