FDA: Page 16

Konica Minolta shows Nano CR line at SIIM
By AuntMinnie.com staff writers
Konica Minolta Medical Imaging USA of Wayne, NJ, gave attendees at last week's Society for Imaging Informatics in Medicine (SIIM) conference in Providence, RI, a look at the company's new compact computed radiography (CR) product.
June 10, 2007
Medtronic submits PMA for Talent Thoracic
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has submitted the final module of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Talent Thoracic stent-graft system.
March 4, 2007
EOS begins clinical trial
By AuntMinnie.com staff writers
Medical device firm Electro-Optical Sciences (EOS) has begun a clinical trial for its MelaFind skin imaging device.
January 31, 2007
FlowCardia receives recanalization 510(k)
By AuntMinnie.com staff writers
Endovascular device developer FlowCardia said that it has received U.S. Food and Drug Administration 510(k) clearance for its Crosser 14 chronic total occlusion (CTO) recanalization system.
January 22, 2007
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
Previous Page
Page 16 of 32
Next Page