Regulatory: Page 136

GE changes Optison labeling
By AuntMinnie.com staff writers
GE Healthcare has modified the patient monitoring and observation requirements for its Optison echocardiography contrast agent.
August 20, 2012
FDA OKs InSightec ExAblate clinical trial
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received approval from the U.S. Food and Drug Administration to begin a phase I clinical trial to evaluate its ExAblate Neuro system for treating patients with tremor-dominant Parkinson's disease.
August 19, 2012
FDA advises imaging for patients with St. Jude leads
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is recommending that patients who have implantable heart defibrillators that use St. Jude Medical's Riata and Riata ST leads receive x-ray or other imaging exams to check for abnormalities in the insulation surrounding the lead.
August 16, 2012
Siemens gets FDA nod for PET amyloid plaque software
By AuntMinnie.com staff writers
Siemens Healthcare has received U.S. Food and Drug Administration clearance for the use of its syngo.PET Amyloid Plaque software with PET and PET/CT scanners.
August 15, 2012
FDA clears expanded use of Pharmalucence imaging agent
By AuntMinnie.com staff writers
Radiopharmaceutical product supplier Pharmalucence said the U.S. Food and Drug Administration has approved the use of its sulfur colloid injection for localizing lymph nodes in patients with malignant melanoma.
August 15, 2012
Radiation therapy fights back against proposed Medicare cuts
By Cynthia E. Keen
Few radiation oncology practices were prepared when the federal government proposed double-digit cuts in Medicare reimbursement in July. But the specialty's defenders are mobilizing to fight back with a major line of attack on the methodology used to justify the payment changes.
August 15, 2012
Houston radiologist settles with justice dept.
By AuntMinnie.com staff writers
Houston radiologist Dr. Jack Baker has agreed to pay $650,000 to settle claims that he violated the False Claims Act, antikickback and Stark laws, and the Texas Medicaid Fraud Prevention Act between 2002 and 2010.
August 14, 2012
AHRA: Uncertainty looms as feds implement healthcare reform
By Kate Madden Yee
In the years since the Patient Protection and Affordable Care Act was passed, U.S. regulators have continued to write rules implementing the law. In such a fluid healthcare environment, it can be difficult for radiology practices to stay on top of the changes, according to a presentation at the AHRA 2012 meeting.
August 13, 2012
Lung group says VA to start CT lung cancer screening
By AuntMinnie.com staff writers
The U.S. Department of Veterans Affairs (VA) will move to begin lung cancer screening in high-risk individuals at its U.S. facilities, according to screening advocacy group Lung Cancer Alliance.
August 12, 2012
ACP warns physicians of 'government overreach'
By AuntMinnie.com staff writers
The American College of Physicians (ACP) is recommending that state and federal governments adopt seven principles to avoid passing legislation that interferes with the patient-physician relationship and appropriate care.
August 9, 2012
HHS releases new rule for healthcare claims
By AuntMinnie.com staff writers
U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius has announced the release of a regulation that adopts operating rules for making healthcare claim payments electronically. The rule also describes adjustments to claim payments.
August 7, 2012
Kubtec earns ISO for x-ray quality management systems
By AuntMinnie.com staff writers
Digital x-ray firm Kub Technologies (Kubtec) said it has been awarded International Organization for Standardization (ISO) 9001 and 13485 certifications for its quality management systems.
August 7, 2012
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