FDA: Page 10

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The U.S. Food and Drug Administration has proposed new guidelines for high-quality clinical studies and a draft guidance to clarify how benefit-risk determinations are made during premarket approval (PMA) review of certain medical devices.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
FDA proposes lower user fees
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration plans to reduce medical device user fees by 7% next year, while at the same time starting a program to offer discounted rates for small medical device firms.
August 1, 2011
IOM report hits FDA 510(k) program, offers ways to correct it
By Wayne Forrest
After 16 months of research, the Institute of Medicine (IOM) has released a report that concludes the U.S. Food and Drug Administration's 510(k) program "lacks the statutory basis to make a reliable premarket screen for safety and effectiveness of class II medical devices."
July 28, 2011
FDA proposes guidance on 510(k) devices
By AuntMinnie.com staff writers
In a move to further simplify and relax some of its device clearance regulations, the U.S. Food and Drug Administration has issued a draft guidance designed to clarify when changes or modifications to previously cleared 510(k) devices require a new premarket submission from manufacturers.
July 25, 2011
FDA to relax 510(k) rules on some devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration today issued a draft guidance that would relax the agency's requirements for 510(k) clearance of some medical devices.
July 6, 2011
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