FDA: Page 16

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
Median gets 510(k) for lung and liver apps
By AuntMinnie.com staff writers
French computer-aided detection (CAD) developer Median Technologies has received 510(k) clearance from the U.S. Food and Drug Administration for its LMS-Lung/Track and LMS-Liver applications.
June 17, 2007
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
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