FDA: Page 9

Syntermed gets 510(k) for nuclear cardiac software
By AuntMinnie.com staff writers
Imaging software developer Syntermed has been awarded 510(k) clearance from the U.S. Food and Drug Administration for its Emory Cardiac Toolbox version 4.0 nuclear cardiac software.
May 19, 2013
VuCOMP secures PMA for digital mammography CAD
By Kate Madden Yee
Some things are worth the wait, believes computer-aided detection (CAD) developer VuCOMP about its newly approved CAD. The company has received premarket approval (PMA) notification for its M-Vu CAD software for digital mammography.
October 17, 2012
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U-Systems lands final clearance for somo.v for dense breasts
By Erik L. Ridley
Automated breast ultrasound technology developer U-Systems has become the first vendor to receive U.S. Food and Drug Administration clearance to market a device specifically for use in screening women with dense breasts.
September 17, 2012
FDA to review Hologic breast tomo extension
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is set to review an application by women's imaging vendor Hologic for an expansion of the clinical indications for its Selenia Dimensions 3D digital breast tomosynthesis mammography system.
August 23, 2012
FDA releases final guidance documents on CAD
By Erik L. Ridley
Nearly three years after the U.S. Food and Drug Administration published draft guidance on how it plans to regulate computer-assisted detection (CAD) technology, the agency has released the final versions.
July 8, 2012
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Hansen nets FDA 510(k) clearance
By AuntMinnie.com staff writers
Robotic technology developer Hansen Medical has received 510(k) clearance from the U.S. Food and Drug Administration for its Magellan robotic system for use in peripheral vascular interventions.
June 7, 2012
U-Systems receives FDA PMA letter for ABUS
By AuntMinnie.com staff writers
Automated breast ultrasound (ABUS) developer U-Systems has received a premarket approval (PMA) letter from the U.S. Food and Drug Administration for its somo.v ABUS system.
May 13, 2012
Novian Health begins breast cancer trial
By AuntMinnie.com staff writers
Novian Health has begun a multicenter clinical trial on the use of its Novilase interstitial laser therapy (ILT) for the destruction of malignant breast tumors, the company said.
April 11, 2012
FDA panel recommends approval for ABUS for breast screening
By Erik L. Ridley
The first U.S. Food and Drug Administration (FDA) approval for an automated breast ultrasound (ABUS) system in breast cancer screening applications moved closer to reality after an FDA panel voted to recommend approval of U-Systems' somo.v system for use in screening of women with dense breasts.
April 10, 2012
Dental x-rays linked to brain tumors; FDA to review ABUS device
By Brian Casey
April 9, 2012
FDA releases guidance for device manufacturers
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has published a guidance document for medical device vendors that spells out how it considers the benefits and risks of certain medical devices during premarket review.
March 26, 2012
U-Systems gets FDA meeting for ABUS
By AuntMinnie.com staff writers
Ultrasound developer U-Systems said that its somo.v automated breast ultrasound system (ABUS) will be reviewed by a U.S. Food and Drug Administration advisory panel on April 11.
February 26, 2012
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