Regulatory: Page 77

FDA eyes risks of gadolinium contrast brain deposits
By Wayne Forrest
The U.S. Food and Drug Administration (FDA) on Monday announced that it will investigate the risk of gadolinium-based contrast agents in the wake of several recent studies that found gadolinium deposits in the brains of some patients years after they received contrast-enhanced MRI scans.
July 26, 2015
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CMS: Medicare funds will last longer than predicted
By AuntMinnie.com staff writers
The fund that finances Medicare's hospital insurance coverage will last more than a decade longer than previously expected, according to a recent report.
July 22, 2015
ASTRO: Proposed MPFS rule would hurt radiation therapy
By AuntMinnie.com staff writers
Reimbursement cuts proposed in the 2016 Medicare Physician Fee Schedule (MPFS) would threaten patient access to community-based radiation therapy, according to the American Society for Radiation Oncology (ASTRO).
July 22, 2015
How to avoid Medicare CT scan payment denials
By Jeff Majchrzak
Are your Medicare claims for CT services at risk of being rejected because they resemble "improper" scans? In this article, Jeff Majchrzak of Panacea Healthcare Solutions describes how to avoid submitting billing reports that raise red flags at the U.S. Centers for Medicare and Medicaid Services.
July 21, 2015
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FDA approves St. Jude Medical's paddle lead
By AuntMinnie.com staff writers
Cardiac technology developer St. Jude Medical has received U.S. Food and Drug Administration (FDA) approval of MR-conditional labeling for its spinal cord stimulation paddle lead.
July 19, 2015
Fuji files PMA module for digital tomo
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration for digital breast tomosynthesis.
July 15, 2015
FDA wants to revise MRI premarket information
By AuntMinnie.com staff writers
The U.S Food and Drug Administration (FDA) is proposing to revise the information vendors should include in their 510(k) premarket submissions for MRI diagnostic devices.
July 14, 2015
Radiology averts cuts in proposed 2016 MPFS
By Kate Madden Yee
Radiology has dodged a bullet in the proposed rule for the 2016 Medicare Physician Fee Schedule (MPFS) released on July 8 by the U.S. Centers for Medicare and Medicaid Services, receiving no payment increases or decreases.
July 8, 2015
Blue Earth gets orphan drug status
By AuntMinnie.com staff writers
Blue Earth Diagnostics has received two orphan drug designations for its F-18 fluciclovine radiopharmaceutical for diagnosing glioma.
July 7, 2015
Lexmark viewer software receives FDA nod
By AuntMinnie.com staff writers
Printing firm and software developer Lexmark International has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NilRead viewer software.
July 7, 2015
New help available for transition to ICD-10
By AuntMinnie.com staff writers
In preparation for the switch from version 9 of the International Classification of Diseases (ICD) to ICD-10 coding for medical diagnoses and inpatient hospital procedures, two groups have released additional guidance.
July 5, 2015
FDA OKs Kubtec's new DR detector
By AuntMinnie.com staff writers
Kubtec has received U.S. Food and Drug Administration (FDA) clearance for its DigiView 395 high-resolution wireless flat-panel digital radiography (DR) detector.
July 5, 2015
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