Regulatory: Page 233

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
Boston nets CE Mark
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received the European CE Mark for its Promus everolimus-eluting coronary stent system.
October 15, 2006
Cook gets CE Mark for endovascular graft
By AuntMinnie.com staff writers
Interventional firm Cook said that it has received European CE Mark approval for its Zenith Branch endovascular graft.
October 9, 2006
NeuroLogica nets CE Mark
By AuntMinnie.com staff writers
Mobile CT developer NeuroLogica has received the European CE Mark for its CereTom portable CT scanner.
October 8, 2006
FDA OKs Rendoscopy's 3D software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has given 510(k) clearance to Rendoscopy's Gentle Colon virtual colonoscopy 3D visualization software.
October 4, 2006
eRad scores CE Mark
By AuntMinnie.com staff writers
PACS firm eRad has received the CE Mark for its PACS offering.
September 27, 2006
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