FDA: Page 11

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further simplify and relax some of its device clearance regulations, the U.S. Food and Drug Administration has issued a draft guidance designed to clarify when changes or modifications to previously cleared 510(k) devices require a new premarket submission from manufacturers.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The U.S. Food and Drug Administration today issued a draft guidance that would relax the agency's requirements for 510(k) clearance of some medical devices.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
U-Systems lands funding
By AuntMinnie.com staff writers
Ultrasound developer U-Systems has finalized a $6.5 million financing round from existing investors and affiliates.
May 8, 2011
FDA approves Sectra full-field digital mammography unit
By Brian Casey
The U.S. Food and Drug Administration announced on Tuesday that it has approved a full-field digital mammography (FFDM) unit from Swedish mammography and PACS developer Sectra. The approval is the latest since the agency revised its rules in November 2010 on new FFDM approvals.
May 2, 2011
FDA asks IDSI for more info on CTLM 510(k)
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) has received notification from the U.S. Food and Drug Administration requesting more information for a 510(k) application it submitted for its CT laser mammography (CTLM) imaging device.
April 6, 2011
Covidien gets FDA nod for Pipeline
By AuntMinnie.com staff writers
Healthcare technology firm Covidien said that the U.S. Food and Drug Administration has approved the premarket approval application for its Pipeline embolization device.
April 6, 2011
Philips gets 510(k) for Ingenia MRI
By AuntMinnie.com staff writers
Philips Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Ingenia MRI system.
April 5, 2011
NeuroLogica gets 510(k) for BodyTom
By AuntMinnie.com staff writers
Portable scanner developer NeuroLogica has received U.S. Food and Drug Administration 510(k) clearance for its BodyTom CT scanner.
March 30, 2011
U-Systems touts US breast screening study
By AuntMinnie.com staff writers
The University of Chicago has completed a reader study to evaluate the somo.v automated breast ultrasound system from U-Systems for detecting breast cancer in women with dense breast tissue.
February 14, 2011
Medicare's imaging volume drops; digital x-ray shifts from CR to DR
By Brian Casey
February 9, 2011
Previous Page
Page 11 of 32
Next Page