• Abbott Point of Care (East Windsor, New Jersey) reported that it has received FDA 510(k) clearance to market its i-Stat Chem 8+ cartridge, a new point-of-care diagnostic test used to quickly assess basic metabolic status of patients in emergency rooms and other critical care settings. The Chem 8+ cartridge is designed for use with the i-Stat, an automated hand-held blood analyzer that performs a comprehensive panel of critical tests at the patient's bedside in only a few minutes, producing lab-quality results that allow healthcare professionals to make on-the-spot diagnosis and treatment decisions for their patients. The Chem 8+ cartridge is a single-use, in vitro diagnostic test that combines a battery of basic metabolic tests with measurements for hematocrit and hemoglobin into a single test. The i-Stat Chem 8+ cartridge provides a rapid snapshot of the most critical homeostatic processes: glycemic control, electrolyte balance and renal function, right at the patient's side and using just a few drops of blood.

• CardiArc (Lubbock, Texas) said it has received 510(k) clearance from the FDA to market its new cardiac single photon emission computed tomography (SPECT) imaging device, which the company said could lead to better cardiac diagnosis and fewer hospitalizations to rule out heart attacks. It said physicians soon would have sharper images of blood flow and function of their patients' hearts, in half the time previously required. CardiArc has developed and patented a new, smaller and faster technology for SPECT with twice the resolution of existing devices. The CardiArc system is the size of an executive chair, runs on 110 volts AC current and fits easily in a 6-by-7 foot exam room without remodeling. The device has no visible moving parts and uses solid-state cadmium zinc telluride technology. Patients sit upright, without rotating or holding their arms over their heads. Scan times range from 2 minutes to 6 minutes at physician discretion. The company said the CardiArc SPECT device has been designed for use in outpatient settings and emergency rooms.

• SenoRx (Aliso Viejo, California) said a study presented at the 2005 American Society of Breast Surgeons meeting in Los Angeles retrospectively analyzed the experience of 45 general surgeons in a variety of practice settings using the SenoRx Gel Mark Ultra biopsy site marking system. The paper concluded that "the Gel Mark Ultra biopsy site marking system is a new biopsy site localization device that provides a safe and effective alternative to traditional localization methods. More importantly, it provides a significant reduction in the frequency of positive margins as well as enhancing surgical efficiency and patient comfort."

• Synbiotics (San Diego) has received conditional approval from the U.S. Department of Agriculture for U.S. marketing and distribution of its Avian Influenza Virus Type A Antigen Test Kit, which provides fast and highly sensitive detection of the virus in poultry, including subtype H5N1. The agency is reviewing Synbiotics' application for full approval. This product already is being marketed in other parts of the world under the trademark Flu Detect. The Flu Detect antigen test kit, launched last spring, detects all 16 sub-types of Influenza Type A and can be used in the laboratory or on the farm.

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