FDA: Page 10

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Nearly three years after the U.S. Food and Drug Administration published draft guidance on how it plans to regulate computer-assisted detection (CAD) technology, the agency has released the final versions.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
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
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