Regulatory: Page 210

Nucletron receives Canadian clearance
By AuntMinnie.com staff writers
Radiation oncology firm Nucletron has received Health Canada clearance for its Oncentra Brachy volume-based treatment planning software.
November 12, 2008
Hologic nets CE Mark for Celero
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received CE Mark approval for its Celero vacuum-assisted spring-loaded core biopsy device.
November 5, 2008
Aurora gets FDA nod for MR spectroscopy
By AuntMinnie.com staff writers
Breast MRI technology developer Aurora Imaging Technology has received U.S. Food and Drug Administration 510(k) clearance for its AuroraSpectroscopy breast MR spectroscopy package.
November 2, 2008
Dune launches MarginProbe trial
By AuntMinnie.com staff writers
Israeli firm Dune Medical Devices has begun a U.S. clinical trial of its MarginProbe intraoperative breast cancer probe.
October 28, 2008
WSJ: FDA supports imaging agents for Alzheimer's
By AuntMinnie.com staff writers
A panel of medical experts from the U.S. Food and Drug Administration says imaging agents currently in development could help doctors diagnose abnormal amyloid plaques in the brain associated with Alzheimer's disease.
October 23, 2008
Merit gets nod for Prelude
By AuntMinnie.com staff writers
Disposable products developer Merit Medical Systems has received U.S. Food and Drug Administration 510(k) clearance for its Prelude short sheath introducer.
October 21, 2008
Acusphere's Imagify to get FDA review
By AuntMinnie.com staff writers
Ultrasound contrast developer Acusphere said that its Imagify contrast agent will be reviewed during a planned public meeting of the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee on December 10.
October 12, 2008
FDA OKs 3D mode for Biospace Med's EOS
By AuntMinnie.com staff writers
French digital radiography developer Biospace Med has received 510(k) clearance from the U.S. Food and Drug Administration for a 3D skeletal reconstruction mode for its EOS digital x-ray system.
October 7, 2008
Sentinelle nets CE Mark
By AuntMinnie.com staff writers
MRI technology developer Sentinelle Medical has received the European CE Mark for its Sentinelle Vanguard breast MR auxiliary table.
October 6, 2008
Hologic gets clearance for breast software
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received U.S. Food and Drug Administration clearance for software designed to assess breast density.
September 30, 2008
Boston Scientific wins FDA nod for small-vessel stent
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received clearance from the U.S. Food and Drug Administration for a drug-eluting stent for small vessels.
September 24, 2008
Covidien gets FDA warning letter
By AuntMinnie.com staff writers
Radiopharmaceutical firm Covidien has received a warning letter from the U.S. Food and Drug Administration for manufacturing issues at a plant that produces the company's Ultra-TechneKow-DTE technetium-99m-based product.
September 24, 2008
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