Regulatory: Page 119

CBO: Medicare should reject prior authorization
By AuntMinnie.com staff writers
The U.S. Congressional Budget Office's (CBO) scoring of President Obama's fiscal 2014 budget shows that use of prior authorization for imaging within the Medicare program would produce no savings, according to a report released on May 17.
May 21, 2013
FDA approves Hologic's 2D breast tomo mode
By AuntMinnie.com staff writers
Women's imaging vendor Hologic said it has received approval from the U.S. Food and Drug Administration for its C-View 2D imaging software for use with its Selenia Dimensions 3D breast tomosynthesis system.
May 20, 2013
2013 05 20 14 53 44 351 Hologic C View 2 450
Syntermed gets 510(k) for nuclear cardiac software
By AuntMinnie.com staff writers
Imaging software developer Syntermed has been awarded 510(k) clearance from the U.S. Food and Drug Administration for its Emory Cardiac Toolbox version 4.0 nuclear cardiac software.
May 19, 2013
Breast density bill signed in Md.
By AuntMinnie.com staff writers
Maryland Gov. Martin O'Malley this week signed a breast density patient notification law, making Maryland the seventh state in the U.S. to implement such legislation.
May 16, 2013
Canadian breast CR study provokes concern
By AuntMinnie.com staff writers
In a study published on May 14 in Radiology, Canadian researchers found that mammography using computed radiography (CR) systems produced lower breast cancer detection rates than analog units or those based on flat-panel digital radiography. The results have caused a furor as Canadian provinces scramble to respond.
May 16, 2013
MiE, NIS get FDA OK for PET upgrade
By AuntMinnie.com staff writers
Medical Imaging Electronics (MiE) and Nuclear Imaging Services (NIS) have received 510(k) clearance from the U.S. Food and Drug Administration for its ECAT Scintron upgrade.
May 15, 2013
FDA clears Bayer's Xofigo
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared the use of radium-223 dichloride to treat patients who have castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.
May 15, 2013
iCRco gets clearance for CR mammo
By AuntMinnie.com staff writers
Computed radiography (CR) firm iCRco has received clearance from the U.S. Food and Drug Administration for its 3600M mammography system.
May 13, 2013
FDA issues report on medical device ID plans
By AuntMinnie.com staff writers
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has published a report providing an update of its plans to require that most medical devices distributed in the U.S. carry a unique device identifier.
May 12, 2013
California's breast density notification law -- 1 month in
By Kate Madden Yee
It's been just over 30 days since California's version of breast density notification legislation went into effect. How is the law affecting clinical practice in the state's breast centers? Although they are complying, many breast imagers are skeptical of its value.
May 8, 2013
2013 05 06 10 55 22 338 Breast Density 200
Signostics gets FDA nod for handheld US device
By AuntMinnie.com staff writers
Australian handheld ultrasound developer Signostics has received U.S. Food and Drug Administration 510(k) clearance for its Signos RT ultrasound system.
May 6, 2013
NJ legislation would require breast density payments
By AuntMinnie.com staff writers
Legislation is advancing in the New Jersey Assembly that would require health insurers to cover additional breast screenings if a mammogram demonstrates dense breast tissue, according to a bill by sponsor Troy Singleton (D-Burlington).
May 6, 2013
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