• 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.

• Advanced Medical Optics (Santa Ana, California) said that its Tecnis foldable intraocular lens (IOL) has been designated as a New Technology Intraocular Lens (NTIOL) by the Centers for Medicare & Medicaid Services (Baltimore). The designation follows labeling claims approved by FDA in April 2004 that the Tecnis foldable IOL reduced postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance. The NTIOL designation goes into effect Feb. 27 and includes both the acrylic and silicone platform Tecnis lenses. The company said the Tecnis IOL is the only lens approved for NTIOL reimbursement status, which provides for additional Medicare reimbursement of $50 per lens for ambulatory surgical centers, which perform more than half of all cataract surgeries in the U.S.

• BrainStorm Cell Therapeutics (Tel Aviv, Israel), developer of NurOwn bone marrow-derived stem cell therapeutic products for the treatment of neurodegenerative diseases, said a patent application has been filed with the U.S. Patent and Trademark Office for a new procedure to derive oligodendrocyte-like cells. The invention involves inducing oligodendrocyte-like cells using the company's bone marrow-derived human mesenchymal stem cell technology. The patent application was filed by Ramot, the technology transfer company of Tel Aviv University, on the basis of research funded by Brainstorm . Worldwide rights to the development and commercialization of the new technology are exclusively licensed to BrainStorm.

• 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-foot by 7-foot exam room without remodeling. The device has no visible moving parts and uses solid-state cadmium zinc telluride (CZT) 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.

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