FDA: Page 15

CTLM with mammo boosts breast cancer diagnosis
By AuntMinnie.com staff writers
CT laser mammography (CTLM) system developer Imaging Diagnostic Systems (IDSI) announced that a new study found that its CTLM system increased the accuracy of diagnosing malignant and benign breast lesions when used as an adjunct to mammography.
December 3, 2008
Medicsight submits 510(k) for ColonCAD
By AuntMinnie.com staff writers
Computer-aided detection developer Medicsight has filed a 510(k) application to the U.S Food and Drug Administration for its ColonCAD image analysis software.
November 19, 2008
CMS gets 510(k) for segmentation software
By AuntMinnie.com staff writers
Radiation therapy planning firm CMS has received U.S. Food and Drug Administration 510(k) clearance for its Atlas-Based Autosegmentation (ABAS) software.
August 21, 2008
FDA releases MRI implant guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has released a new guidance document covering the use of passive implants in MRI environments.
August 21, 2008
Meta Imaging nets 510(k) for breast system
By AuntMinnie.com staff writers
Meta Imaging Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its Chrysalis breast displacement system.
August 19, 2008
Medrad gets 510(k) for FDG infusion system
By AuntMinnie.com staff writers
Contrast injector technology firm Medrad has received 510(k) clearance from the U.S. Food and Drug Administration for Intego, a PET radiopharmaceutical infusion system.
June 17, 2008
FDA to ease rules on digital mammography systems
By Brian Casey
June 9, 2008
FDA proposes easier regulatory path for FFDM systems
By Cynthia E. Keen
The U.S. Food and Drug Administration is proposing changes to the way it regulates full-field digital mammography (FFDM) systems. The move should make it easier and less costly for mammography vendors to bring FFDM systems to market when the new rules are scheduled to go into effect in 2009.
June 9, 2008
NordicNeuroLab nets 510(k) for new software
By AuntMinnie.com staff writers
Norwegian functional MRI developer NordicNeuroLab has received 510(k) clearance from the U.S. Food and Drug Administration to market its nordicAktiva software.
June 2, 2008
Grable returns to IDSI
By AuntMinnie.com staff writers
Linda B. Grable, co-founder of Imaging Diagnostic Systems (IDSI), has come out of retirement to again become chairman and CEO of the Plantation, FL, company.
April 23, 2008
CMS applies for 510(k) for RTP software
By AuntMinnie.com staff writers
Radiation treatment planning firm CMS of St. Louis has applied to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of its CMS Atlas-Based Autosegmentation software.
April 20, 2008
BSD Medical posts healthy Q1 results
By AuntMinnie.com staff writers
Brachytherapy and hyperthermia therapy developer BSD Medical of Salt Lake City posted its first-quarter financial results, the company said.
January 9, 2008
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