Naviscan Inc. said the FDA has granted 510(k) clearance for its biopsy-guidance feature designed exclusively for use with its high-resolution organ-specific PET scanner, Positron Emission Mammography (PEM).

Stereo Navigator, the PEM-guided biopsy accessory, is indicated for the localization of lesions in female breasts, as identified on a PET image. This guidance system is designed to enable physicians to guide compatible interventional devices towards abnormalities visible on PET.

Mindray's DC-3 color ultrasound imaging system is equipped with extensive applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets.

This new system combines 2D imaging and color Doppler performance and is suited for hospitals, doctors' offices and clinics in hopes of replacing black and white ultrasound imaging systems.

November 19, 2008 - IntraOp Medical Corp. announced its second German order for the Mobetron, which delivers intraoperative electron-beam radiation therapy (IOERT) to cancer patients.
The University Hospital Giessen and Marburg GmbH (Marburg), located in Marburg, Germany will be the second Mobetron installation in Germany. The first is the Strahleninstitut in Cologne.

November 18, 2008 — Carestream Health Inc. and National Digital Medical Archive Inc. (NDMA) are collaborating on product integration initiatives designed to support the expansion of NDMA’s national imaging network and improve customer access to its analytics and data management services.

November 19, 2008 - Image Medical Corporation, parent of eRAD Inc. said that Robert S. Pryor has been appointed to Image Medical’s Board of Directors.

November 18, 2008 - Medicsight PLC has submitted for a 510(k) Premarket Notification to the FDA for clearance to market its ColonCAD image analysis software throughout the U.S.

November 19, 2008 - Merge Healthcare today released its MergeCOM-3 Version 3.9, which adds the latest DICOM standard supplements to its DICOM toolkit.

November 19, 2008 - U.S. Reps. John Dingell (D-MI), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, yesterday launched an investigation into whether managers within the FDA Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications in violation of laws and regulations designed to assure the safety and effectiveness of medical devices.

With the full integration of GE Healthcare's (GE) Innova system with Volcano's s5i IVUS system, there is no need to roll around your IVUS unit. Through its collaboration with Volcano Corp., GE offers Innova IVUS as a fully integrated intravascular ultrasound system for the cath lab and interventional suite.

Volcano's IVUS automated features include: automatic border detection to identify lumen and vessel walls; automatic measurements to quantify lumen and vessel areas and diameters and plaque burder; and real-time VH IVUS to identify the type and amount of plaque present.

GE Healthcare's Innova 4100IQ is a large-format digital flat-panel X-ray system for angiographic imaging that incorporates GE’s exclusive Innova single piece, non-tiled digital detector (41cm-by-41 cm) to provide high-resolution imaging across the full range of vascular and interventional applications.

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