Regulatory: Page 125

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
USPSTF to revisit carotid artery stenosis screening
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) plans to review its guidelines on the use of imaging to screen patients for asymptomatic carotid artery stenosis.
January 15, 2013
GE files sNDA to manufacture Optison
By AuntMinnie.com staff writers
GE Healthcare has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration that would allow the company to manufacture its Optison ultrasound contrast agent at its own manufacturing facility.
January 14, 2013
Viztek lands FDA nod for DR panels
By AuntMinnie.com staff writers
Imaging informatics firm Viztek has received U.S. Food and Drug Administration 510(k) clearance for its ViZion + DR line of digital radiography (DR) panels.
January 14, 2013
InfoGard receives ONC authorization
By AuntMinnie.com staff writers
Information assurance and security company InfoGard Laboratories has been authorized as a U.S. Office of the National Coordinator Authorized Testing and Certification Body (ONC-ATCB).
January 14, 2013
CMS issues new meaningful use guidance
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has provided new guidance that clarifies the eligibility of certain radiologists for the "significant hardship" exception added in stage 2 of its meaningful use IT incentive program.
January 9, 2013
Riverain gets 510(k) for device placement software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared new software from Riverain Technologies that improves the clarity of conventional chest x-ray images and allows radiologists to confirm the proper placement of medical devices, according to the company.
January 8, 2013
GE files applications for F-18 flutemetamol
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration and the European Medicines Agency have accepted applications from GE Healthcare for review of its investigational F-18 flutemetamol PET amyloid imaging agent.
January 7, 2013
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