Regulatory: Page 126

CMS committee not yet swayed on brain amyloid PET imaging
By Wayne Forrest
A U.S. Centers for Medicare and Medicaid Services (CMS) advisory committee said on Wednesday that more studies are needed to confirm the efficacy of Eli Lilly and Avid Radiopharmaceuticals' Amyvid radiopharmaceutical for brain beta-amyloid PET imaging.
January 30, 2013
Manufacturer coalition makes 1st device tax payment
By AuntMinnie.com staff writers
A coalition of medical device manufacturers has made a first semimonthly medical device tax payment to the Internal Revenue Service (IRS) of $97 million, a tax that it says is threatening hundreds of thousands of jobs and innovation.
January 29, 2013
FDA offers grants for CDRH radiation protection program
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration will provide grant funds in support of the Center for Devices and Radiological Health (CDRH) 2013 Assuring Radiation Protection program.
January 28, 2013
Augmenix gets FDA clearance for tissue marker
By AuntMinnie.com staff writers
Radiation oncology products developer Augmenix announced that it has received U.S. Food and Drug Administration 510(k) clearance for its TraceIT tissue marker.
January 27, 2013
Varian gets FDA clearances, Algerian order
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for two of the company's products.
January 23, 2013
ACR supports repeal of Medicare payment panel
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has sent a letter to members of the U.S. House of Representatives expressing support for the repeal of a new panel designed to target areas of Medicare for spending reductions.
January 23, 2013
HHS announces changes in HIPAA privacy laws
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) said it has taken steps to strengthen healthcare privacy and security protections established under HIPAA.
January 20, 2013
House hearing to eye federal IT purchasing
By AuntMinnie.com staff writers
The U.S. House of Representatives' Oversight and Government Reform Committee is starting the new 113th Congress by scheduling a hearing on January 22 to focus on "the wasteful and dysfunctional fashion in which the federal government acquires information technology systems and services."
January 20, 2013
Biotronik gets conditional FDA approval for ProMRI trial
By AuntMinnie.com staff writers
Biomedical device company Biotronik has received approval with conditions from the U.S. Food and Drug Administration for the company's ProMRI clinical trial via an investigational device exemption.
January 17, 2013
SGR patch, 2013 edition: What just happened?
By Kate Madden Yee
It's become a recurring end-of-year political drama: Congress scrambles to ward off massive cuts to Medicare reimbursement with a temporary patch of the sustainable growth rate (SGR) formula. But this year's SGR theatrics came to a shocking climax: a stab in the back for radiology.
January 16, 2013
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CCHIT obtains ONC MU certification
By AuntMinnie.com staff writers
The Certification Commission for Health Information Technology (CCHIT) has been authorized by the U.S. Office of the National Coordinator (ONC) to certify electronic health records used to comply with meaningful use (MU) requirements.
January 15, 2013
Lilly's Amyvid PET agent gets European clearance
By AuntMinnie.com staff writers
Eli Lilly and its subsidiary Avid Radiopharmaceuticals have received approval from the European Commission for their Amyvid (florbetapir F-18) radiopharmaceutical.
January 15, 2013
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