FDA: Page 17

Kodak files for Canadian OK of CR mammo system
By AuntMinnie.com staff writers
Eastman Kodak Health Group of Rochester, NY, has filed an application with Health Canada for regulatory clearance of its computed radiography (CR) system for mammography.
December 18, 2006
IDSI forms Italian CT laser mammography firm
By AuntMinnie.com staff writers
CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) has inked a multiyear distribution deal with CTLM Italia, a new company established to market IDSI's CTLM imaging system in Italy.
November 26, 2006
eRad nets 510(k) for mammography viewing
By AuntMinnie.com staff writers
PACS firm eRad reported that it has received U.S. Food and Drug Administration 510(k) clearance for soft-copy viewing of digital mammography images.
November 16, 2006
Viasys receives 510(k)
By AuntMinnie.com staff writers
Medical technology developer Viasys Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Sonora and Sonora/tek digital transcranial Doppler ultrasound systems.
November 14, 2006
NAS receives 510(k) for ClearPath
By AuntMinnie.com staff writers
Radiation therapy products developer North American Scientific (NAS) said it has received 510(k) clearance from the U.S Food and Drug Administration to market the high-dose-rate radiation treatment design of ClearPath, a multicatheter breast brachytherapy device.
November 13, 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
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
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
EndoCare gets 510(k) for cryoablation device
By AuntMinnie.com staff writers
Cryoablation vendor Endocare has received 510(k) clearance from the U.S. Food and Drug Administration to market its new Cryocare CN2 system.
September 11, 2006
FDA panel rejects Mirabel impedance breast device
By AuntMinnie.com staff writers
A U.S. Food and Drug Administration advisory committee last week voted unanimously that the premarket approval (PMA) application for a breast impedance imaging device be found "not approvable."
September 7, 2006
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