Gen-Probe (San Diego) reported that the FDA has granted marketing clearance for its Aptima assay for Neisseria gonorrhoeae (GC), an amplified nucleic acid test that detects, on a standalone basis, the bacterium that causes one of the most common sexually transmitted diseases in the U.S. Gen-Probe said it is "the only company that can offer customers two nucleic acid tests that detect different parts of the GC genome." Gen-Probe's primary amplified STD test is the Aptima Combo 2 assay, which simultaneously detects Chlamydia trachomatis and GC. The Aptima GC assay was cleared to detect GC from a variety of sample types: clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. The Aptima assays can be run on Gen-Probe's semi-automated direct tube sampling instruments.
FlowMedica (Fremont, California) said the Benephit Delta Infusion System, a new device that provides administration of physician-specified medications and other therapeutic agents directly to the renal arteries, has received 510(k) clearance from the FDA. The Benephit Delta system is designed for patients with kidney dysfunction who may benefit from targeted renal therapy (TRT), including those with congestive heart failure. TRT is an alternative to the standard delivery method of systemic intravenous infusion of medications to treat kidney dysfunction that is related to a number of conditions. The FDA previously granted 510(k) clearance to the Benephit Infusion System, which typically is used to provide TRT in conjunction with minimally invasive interventional procedures for the diagnosis or treatment of cardiovascular disease. The reduced profile, increased flexibility, and longer lengths of the Benephit Delta system allow for access through arterial sites. The system is designed to allow greater patient mobility and ease in providing therapy once the patient leaves the interventional laboratory.
Nanogen (San Diego), developer of advanced diagnostic products, reported that it was issued U.S. patent No. 6,864,071 by the U.S. Patent and Trademark Office. The patent relates to amplifying and analyzing multiple samples of nucleic acid using ligation-based strand displacement amplification (SDA) technologies. The intellectual property pertains to research Nanogen conducted in collaboration with Becton Dickinson (Franklin Lakes, New Jersey) and increases Nanogen's portfolio of technologies for multiplex amplification on a chip. The combination of SDA and Nanogen chip technologies makes it possible to conduct multiplex amplification, detection and analysis of multiple samples within a single electronic microarray. SDA is an isothermal amplification process that uses a series of primers, DNA polymerase and a restriction enzyme to exponentially amplify the target nucleic acid sequence.
Siemens Medical Solutions (Mountain View, California) introduced the all-digital Sonoline G40 ultrasound imaging system. Siemens said the G40 combines "best-in-class" image quality, workflow advancements and color Doppler capabilities to meet daily clinical needs in a variety of settings. Embedded connectivity solutions allow simple integration into DICOM-enabled networks and PC-based workstations. Phased array technology also expands clinical capabilities to include cardiac survey and small-footprint abdominal imaging. Other advances include Virtual Format Imaging, which offers a variety of linear, trapezoidal and steered 2-D imaging formats. The G40 system is expected to be available for purchase next month.
Spacelabs Medical (Issaquah, Washington) has introduced TruLink SpO2 Sensors, a new line of reusable and single-patient use pulse oximetry sensors, in a variety of sizes ranging from neonate to adult. TruLink SpO2 Sensors can be used with all Spacelabs Ultraview Command Modules and UltraviewSL Command Modules. The new line is also compatible with a wide variety of other manufacturers' patient monitors as well as Nellcor (Pleasanton, California) pulse oximeters. The "C" shape design of the single-patient use sensors affords an improved fit for patient comfort and can be reapplied to the same patient. Reusable sensors include both a finger clip and "Y" probe that are convenient to apply and provide a secure fit to a range of patients.
Stratagene (Garden Grove, California), a manufacturer of specialized research and diagnostic products, reported that its wholly owned subsidiary, Hycor Biomedical, has received FDA clearance to market its Anti-Tissue Transglutaminase (tTG) IgG autoimmune test. tTG is used in the diagnosis of celiac disease. The new test complements the tTG IgA test cleared by the FDA in 2004. The company said all of its tests can be performed using a manual procedure or the procedures can be fully automated by using its HY-TEC 288 Plus Automated Immunoassay System.
Tensys Medical (San Diego), a leader in real-time blood pressure management, reported the introduction of the TL-150, a continuous, non-invasive blood pressure monitoring system with accuracy clinically proven equivalent to an arterial line. The company said the TL-150 introduces significant technological advancements over the original T-Line system, including improvements such as reduced set-up time and improved motion tolerance. The non-invasive, beat-to-beat capability of the new TL-150 enables continuous monitoring of even the most difficult surgical patients and provides the confidence of real-time feedback on the impact of interventions for optimal blood pressure management, Tensys said.
Toshiba Medical Systems (Tokyo) reported the beginning of patient evaluations in the industry's first multi-center clinical study on coronary computed tomography angiography (CTA) imaging using 64-slice CT technology. Initial results of the study will be released in 2006. In November 2004, Toshiba launched CorE 64 (Coronary Evaluation on 64), an international collaboration with its partners to investigate the use of multislice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization. The patient evaluations will involve non-invasive diagnostic imaging of cardiac patients using Toshiba's CT technologies, such as the Aquilion CFX 64-slice CT, 64-row Quantum Detector and SURECardio and SUREPlaque applications for a period of several months, as well as regular meetings with the study group to measure and discuss the clinical effectiveness of cardiac CT imaging against cardiac catheterizations.