FDA: Page 17

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
GE, Volcano get 510(k) for integrated DR/US product
By AuntMinnie.com staff writers
Multimodality vendor GE Healthcare and intravascular ultrasound (IVUS) developer Volcano of Rancho Cordova, CA, said that they have received U.S. Food and Drug Administration 510(k) clearance to integrate products.
August 23, 2006
Calypso receives 510(k)
By AuntMinnie.com staff writers
Electromagnetic localization developer Calypso Medical Technologies has been granted 510(k) clearance by the U.S. Food and Drug Administration for its Calypso 4D localization system.
August 7, 2006
Fuji CR mammo approval offers new option for breast imaging
By Kate Madden Yee
Fujifilm Medical Systems USA announced today that the FDA has given final approval to its premarket approval (PMA) application for a full-field digital mammography (FFDM) system based on computed radiography (CR) technology. The approval gives breast imaging facilities a new option for going digital that should prove to be more economical than FFDM systems currently on the market, according to this Technology Review article.
July 10, 2006
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Planmed submits PMA for Nuance FFDM
By AuntMinnie.com staff writers
Planmed of Roselle, IL, has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its Planmed Nuance full-field digital mammography (FFDM) system.
June 29, 2006
Medtronic to bring Endeavor to China
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received regulatory approval from the government of the People's Republic of China for its Endeavor drug-eluting coronary stent system.
June 20, 2006
St. Jude Medical gets CE Mark
By AuntMinnie.com staff writers
Medical device manufacturer St. Jude Medical of St. Paul, MN, reported that it has received European CE Mark approval for its QuickOpt timing cycle optimization application.
June 15, 2006
FDA awards 510(k) to Barco's CardiaMetrix
By AuntMinnie.com staff writers
Image display and advanced visualization software developer Barco of Kortrijk, Belgium, has received 510(k) clearance from the U.S. Food and Drug Administration for its CardiaMetrix software.
June 13, 2006
Fuji mammo CR gets FDA nod
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration for its computed radiography for mammography (FCRm) device.
May 30, 2006
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