Regulatory: Page 176

Elekta nets FDA OK for XiO
By AuntMinnie.com staff writers
Oncology firm Elekta has received U.S. Food and Drug Administration 510(k) clearance for its XiO spot scanning treatment planning software.
December 2, 2010
Radiologists expand proactive dose safety efforts
By Edward Susman
CHICAGO - Experts involved in the use of ionizing radiation for diagnostic purposes -- clearly embracing a "better safe than sorry" approach -- outlined a series of measures aimed at reducing the potential risk of imaging studies causing cancer in patients.
December 1, 2010
Obama signs SGR extension
By AuntMinnie.com staff writers
On Tuesday, President Barack Obama signed legislation that temporarily halts the 23% cut in physician payments under the sustainable growth rate (SGR) formula that had been scheduled to take effect on December 1.
November 30, 2010
Imaging3 to resubmit 510(k) application
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 announced it will resubmit an application to the U.S. Food and Drug Administration under the FDA's 510(k) process for its Dominion volumetric imaging scanner.
November 28, 2010
House passes 1-month SGR extension
By AuntMinnie.com staff writers
On Monday, the U.S. House of Representatives passed a bill temporarily halting the 23% cut in physician payments under the sustainable growth rate (SGR) formula, scheduled to take effect on December 1. The Senate has already passed the bill, so it now goes to President Barack Obama for signing.
November 28, 2010
Cardiac PET payments to drop 23% in 2011 due to HOPPS cuts
By Wayne Forrest
Healthcare facilities and imaging centers in the U.S. struggling with lower reimbursement rates will face another challenge next year, as payments for PET myocardial perfusion imaging will decrease from $1,433 to $1,099.
November 25, 2010
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Omega gets FDA nod for flat-panel options
By AuntMinnie.com staff writers
Imaging technology developer Omega Medical Imaging has received U.S. Food and Drug Administration 510(k) clearance for its flat-panel detector technology.
November 24, 2010
IDSI submits 510(k) for CTLM
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) this week submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its CT laser mammography (CTLM) breast imaging device.
November 22, 2010
Hologic's Selenia nets FDA letter
By AuntMinnie.com staff writers
Women's healthcare vendor Hologic has received an approvable letter from the U.S. Food and Drug Administration for the Selenia Dimensions 3D digital mammography tomosynthesis system.
November 22, 2010
Mammotome gets FDA nod
By AuntMinnie.com staff writers
Breast biopsy developer Mammotome has received U.S. Food and Drug Administration 510(k) clearance for its Mammotome Molecular Imaging (MI) system.
November 22, 2010
FDA 510(k) process unpredictable and costly, study indicates
By Wayne Forrest
A survey of some 200 medical device companies by Stanford University in Stanford, CA, shows that many respondents view the current premarket clearance process by the U.S. Food and Drug Administration as unpredictable and plagued by disruptions and delays.
November 21, 2010
Senate passes 1-month SGR extension
By AuntMinnie.com staff writers
On Thursday, the U.S. Senate passed a bill that yet again would stave off cuts to physician payments under the sustainable growth rate (SGR) formula, according to a statement from the Senate Finance Committee.
November 18, 2010
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