Regulatory: Page 232

BioSphere gets FDA nod for QuadraSphere
By AuntMinnie.com staff writers
Interventional device developer BioSphere Medical reported that the U.S. Food and Drug Administration has cleared the 510(k) application for the company's QuadraSphere microspheres.
November 8, 2006
Kodak submits final FDA data for approval of mammo CR
By AuntMinnie.com staff writers
Eastman Kodak Health Group said it has submitted the final module of a premarket approval (PMA) submission to the U.S. Food and Drug Administration for approval of its computed radiography (CR) system for mammography applications.
November 8, 2006
Planmed
By Kate Madden Yee
Planmed of Roselle, IL, plans to showcase Nuance, a work-in-progress full-field digital mammography unit with amorphous selenium detectors that come in large and small sizes.
November 8, 2006
Epix nets Canadian OK for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received approval from Health Canada's Health Products and Food Branch (HPFB) for its Vasovist blood-pool MR angiography contrast agent.
November 5, 2006
Boston to bring Liberte to Japan
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received Japanese Ministry of Health, Labor and Welfare (MHLW) approval to market its Liberte bare-metal coronary stent system.
November 5, 2006
Siemens Medical Solutions
By Brian Casey
The Malvern, PA, multimodality vendor will use its RSNA exhibit to tout a range of new computer-aided detection (CAD) applications, from chest to mammography.
November 2, 2006
Cook receives FDA clearance for Zenith AAA graft
By AuntMinnie.com staff writers
Interventional firm Cook said it has received U.S. Food and Drug Administration clearance for its 36mm Zenith Flex AAA endovascular graft for the treatment of abdominal aortic aneurysms (AAA).
October 30, 2006
CCHIT certifies 11 ambulatory EHR systems
By AuntMinnie.com staff writers
The Certification Commission for Healthcare Information Technology (CCHIT) has certified 11 of the 17 EHR products it received for certification review in August.
October 29, 2006
Toshiba gets FDA nod for injector option
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received U.S. Food and Drug Administration (FDA) clearance for a new CAN Level 1 injector synchronization option for its Aquilion 64- and 32-slice CT scanners.
October 29, 2006
Fujifilm Medical Systems USA
By Robert Bruce
The big news for Fuji in 2006 was the company's receipt of marketing clearance for its FCRm computed-radiography-based digital mammography system. Also look for Stamford, CT-based Fuji to discuss recent advancements to its line of CR products.
October 29, 2006
FDA gives Siemens PMA for lung CAD
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has signed off on a premarket approval (PMA) application from Siemens Medical Solutions for its syngo Lung computer-aided detection (CAD) software for assisting radiologists in the detection of solid lung nodules in CT chest exams.
October 19, 2006
InfraReDx receives FDA clearance
By AuntMinnie.com staff writers
Coronary imaging developer InfraReDx reported that the U.S. Food and Drug Administration has issued 510(k) clearance for the company to market its near-infrared (NIR) spectroscopic system for examining coronary arteries.
October 18, 2006
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