CardioDynamics (San Diego), a manufacturer of impedance cardiography (ICG) technology, reported that the FDA has granted 510(k) clearance for the second phase of the BioZ Dx — which it said is the first ICG device with 12-lead electrocardiography (ECG). Market release is expected next month. The BioZ Dx is the result of a co-development partnership between the company and Philips Medical Systems (Andover, Massachusetts) and gives physicians the ability to assess the patient's electrical and mechanical cardiovascular status in one efficient platform. Existing BioZ Dx customers will be able to add the 12-lead diagnostic ECG capability with a field upgrade. With four dual sensors, the ICG portion of the BioZ Dx provides 12 parameters about the heart's pumping ability, including the amount of blood ejected by the heart each minute, the resistance it has to work against, and the amount of fluid in the chest.
Metrika (Sunnyvale, California), a manufacturer of diabetes monitoring products, said it received FDA marketing clearance for its new A1cNow INView multi-test system for monitoring hemoglobin A1C — the gold standard indicator of diabetes control. Used in a physician's office or at home, the small monitor provides immediate, lab-quality quantitative A1C test results for determining a person's average blood sugar level over the past two or three months. The test requires only a 10-microliter whole-blood sample via finger stick to obtain lab-quality results.
Toshiba America Medical Systems (Tustin, California) unveiled the Xario ultrasound system, its latest cardiac ultrasound offering, at the American Society of Echocardio-graphy meeting in Boston. The Xario ultrasound system quickly and accurately delivers the high-quality images necessary to distinguish tiny cardiac and vascular structures, while remaining affordable for hospitals and clinics. The Xario ultrasound system delivers superior images to ensure diagnostic confidence. Among its many standard features, including Filter and Pulse Subtraction THI and Harmonic TDI, the Xario provides premier image quality during routine examinations of the heart, as well as when imaging difficult-to-scan patients. In addition, the Xario provides a comprehensive optional Stress Echo package. Cardiologists can print, store and perform network transfers of patient data, still images, clips and SR. The system supports all seven classes of DICOM connectivity, and the patient browser enables cardiologists to review studies and export them to PC-compatible formats at the touch of a button. The system also includes a CDR, integrated DVD recorder and DVI interfaces.