FDA: Page 17

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
Medtronic completes PMA filing for Talent
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has filed the final module of its premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its Talent abdominal stent graft system.
December 2, 2007
IDSI adds CTLM trial site
By AuntMinnie.com staff writers
CT laser mammography (CTLM) system developer Imaging Diagnostic Systems (IDSI) of Plantation, FL, has signed the 10th U.S. site to participate in its CTLM clinical trial.
November 28, 2007
IDSI sells HQ for $4.4 million in leaseback deal
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) of Plantation, FL, has sold its headquarters building for $4.4 million in cash pursuant to a sale/leaseback agreement.
September 18, 2007
BSD Medical clears first PMA hurtle
By AuntMinnie.com staff writers
Brachytherapy and hyperthermia therapy developer BSD Medical of Salt Lake City met a milestone in its premarket approval (PMA) application process with the U.S. Food and Drug Administration (FDA).
August 22, 2007
Medipattern finalizes financing deal
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Medipattern of Toronto has completed a deal to raise nearly $5 million (U.S.) by selling shares to a Canadian investment firm.
August 1, 2007
Biospace files 510(k) application
By AuntMinnie.com staff writers
French digital radiography developer Biospace Med has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its EOS orthopedic 2D/3D x-ray imager.
July 8, 2007
Imaging3 files 510(k) for Dominion 3D
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 has filed a 510(k) submission for its Dominion 3D real-time imaging device with the U.S. Food and Drug Administration (FDA).
June 18, 2007
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