FDA: Page 10

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
VuCOMP gets PMA for mammo CAD software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) company VuCOMP has received premarket approval from the U.S. Food and Drug Administration for M-Vu, the firm's software for film-based mammography CAD.
February 1, 2012
InSightec submits PMA for ExAblate
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its ExAblate treatment for palliation of pain from bone metastases.
January 23, 2012
FDA to ease 510(k) rules on some devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a guidance that will relax the agency's requirements for 510(k) clearance for some medical devices.
December 20, 2011
FDA accepts U-Systems' PMA for ABUS
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has accepted ultrasound developer U-Systems' premarket approval (PMA) application for use of the firm's somo.v automated breast ultrasound (ABUS) system for breast cancer screening.
November 9, 2011
GE starts PMA process for digital breast tomo
By AuntMinnie.com staff writers
GE Healthcare has submitted to the U.S. Food and Drug Administration the first module of its premarket approval (PMA) application for a digital breast tomosynthesis system.
November 9, 2011
Eizo Nanao gets 510(k) for monitor
By AuntMinnie.com staff writers
Display provider Eizo Nanao Technologies has received 510(k) clearance from the U.S Food and Drug Administration for its RadiForce LS560W monitor with LMM 56800 medical display system for use in interventional radiology and surgical suites.
September 28, 2011
FDA proposes new PMA guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has proposed new guidelines for high-quality clinical studies and a draft guidance to clarify how benefit-risk determinations are made during premarket approval (PMA) review of certain medical devices.
August 14, 2011
FDA to require PMA for IDSI system
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration will require Imaging Diagnostic Systems (IDSI) to file a premarket approval (PMA) application rather than a 510(k) for its CT laser mammography (CTLM) system.
August 8, 2011
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