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 - 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.
November 18, 2008 – The House Energy and Commerce Committee launched an investigation yesterday into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns.
November 18, 2008 - Dilon Technologies Inc. said today that they have formed an alliance with Terason Ultrasound to offer an expanded imaging capability when molecular breast imaging and ultrasound may be required.
November 18, 2008 - Riverain Medical said its OnGuard Chest X-ray CAD system and the SoftView Enhanced Chest Imaging technology are commercially available in the European Union and Canada after being awarded CE marks and Canadian device licenses.
November 18, 2008 - AMICAS Inc. will unveil its next generation PACS, Version 6.0, at the 2008 Radiological Society of North America (RSNA) annual meeting from November 30 to December 5, 2008, in Chicago, IL.
AMICAS PACS Version 6.0 introduces intrinsic 3D, a mammography workflow, advanced personalization and hanging protocols, and patient-centric reading to the radiology marketplace.
November 18, 2008 - NeuroNexus Technologies and Philips Research said today that they have signed a joint research agreement to develop next-generation deep brain stimulation devices with the ambition to improve the treatment of neurological diseases and psychiatric disorders.