• Arbor Vita (Sunnyvale, California) said it has received FDA clearance for its AVantage A/H5N1 Flu Test, a more rapid test for the detection of influenza A/H5N1, a disease-causing subtype of the avian influenza A virus that can infect humans. The AVantage A/H5N1 Flu Test detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein — NS1 — that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results. "This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health. "The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu."

• Astra Tech (Waltham, Massachusetts) has reported the enhancement of its online Atlantis WebOrder system with the addition of Atlantis 3-D viewer. The Atlantis 3-D viewer allows for optimized 360 review of Atlantis abutment designs before final production of the abutment. This internet-based feature gives Astra Tech customers 24/7 access to view their Atlantis case images. Atlantis abutments are designed and fabricated using Atlantis VAD (Virtual Abutment Design) system, a patented process that combines 3-D optical scanning, advanced software, and manufacturing methods to deliver patient-specific abutments that eliminates the need for hand modification. Atlantis abutments help to expand the possibilities for cement-retained implant restorations and are available for all major implant systems and in the materials titanium, gold-shaded titanium and zirconia.

• InSightec (Tirat Carmel, Israel) said that the FDA approved a label change for the company's ExAblate 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue. The company says that the ExAblate is the first system to use the MR guided focused ultrasound technology that combines MRI – to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time – and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, provided by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared.

• Vasomedical (Westbury, New York) said it has received FDA clearance to market Vasomedical-BIOX 1305 ECG Holter Monitor and CB Series Ambulatory ECG Analysis Software. The Vasomedical-BIOX 1305 Holter Monitor is the latest addition to Vasomedical's product line. The Model 1305, which has already received CE-mark certification to market in the EU countries, is a compact, lightweight, 3-channel ECG Holter monitor designed for monitoring a patient's cardiac rhythm for 24 to 72 hours and recording ECG on a standard SD memory card. It features a high signal sampling rate and high resolution digital recording for comprehensive data analysis. The data recorded on the 1305 monitor is utilized in the early detection of cardiac abnormalities such as ischemia and arrhythmia.

• Virtual Radiologic (Minneapolis) has received FDA approval for its own developed picture archiving and communications system (vRad PACS). Virtual Radiologic will introduce the software to its affiliated radiologists over the next several months, gradually replacing the commercial software it currently licenses. Virtual Radiologic has in excess of 135 contracted affiliated radiologists located across the nation who will interpret more than 2-1/2 million diagnostic images this year through its teleradiology technology and workflow platform. vRad PACS incorporates a number of features suggested by these radiologists for ease of use and reading efficiency.

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