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Regulatory: Page 65
Fuji applies for DBT software upgrade
By
AuntMinnie.com staff writers
Fujifilm Medical Systems USA has submitted the final module of its premarket approval (PMA) application for digital breast tomosynthesis (DBT) to the U.S. Food and Drug Administration.
August 24, 2016
ACR urges Medicare payment for CT colonography
By
AuntMinnie.com staff writers
The American College of Radiology (ACR) has issued a statement urging the U.S. Centers for Medicare and Medicaid Services to approve reimbursement of CT colonography for senior citizens.
August 14, 2016
MRS certified for ACR's national mammo database
By
AuntMinnie.com staff writers
Mammography Reporting System (MRS) has been certified for version 3.0 of the National Mammography Database, developed by the American College of Radiology (ACR).
August 11, 2016
FDA to hold mammo quality committee meeting
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) will hold a public advisory committee meeting of the National Mammography Quality Assurance Advisory Committee on September 15 in Gaithersburg, MD.
August 9, 2016
FDA issues draft update for medical device changes
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) said it has issued updated draft recommendations on new 510(k) filings for medical device modifications.
August 4, 2016
Comment period for VA nursing rules closes July 25
By
AuntMinnie.com staff writers
The public comment period closes on July 25 for a controversial proposal that would give nurses more authority over medical imaging exams at facilities in the U.S. Department of Veterans Affairs (VA) healthcare system.
July 21, 2016
Calgary Scientific debuts ResolutionMD in Taiwan
By
AuntMinnie.com staff writers
Imaging software developer Calgary Scientific said that its ResolutionMD imaging software has been registered by the Ministry of Health and Welfare of Taiwan.
July 18, 2016
Varian receives FDA registration for collimators
By
AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems received U.S. Food and Drug Administration (FDA) registration for its Claymount Optica 20 and Optica 40 collimators.
July 17, 2016
Could MACRA implementation be delayed?
By
Kate Madden Yee
The U.S. Centers for Medicare and Medicaid Services (CMS) is mulling over various options for implementing the Medicare Access and CHIP Reauthorization Act (MACRA), including potentially pushing back the start date, according to acting CMS administrator Andy Slavitt.
July 13, 2016
Proposed 2017 MPFS is a mixed bag for radiology
By
Kate Madden Yee
When the U.S. Centers for Medicare and Medicaid Services releases its proposed Medicare Physician Fee Schedule (MPFS) each year, the news isn't always good. For 2017, the proposed rule is a typical mishmash, containing some provisions that benefit radiology and some that don't.
July 13, 2016
FDA officials call for new device reporting program
By
AuntMinnie.com staff writers
A new nationwide system for more effectively tracking and reporting problems with medical devices could be implemented by unifying various medical data reporting systems, according to an article published July 11 in the
Journal of the American Medical Association
by top officials with the U.S. Food and Drug Administration (FDA).
July 10, 2016
FDA OKs InSightec's MRgFUS tremor treatment device
By
AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer InSightec has received approval from the U.S. Food and Drug Administration (FDA) for its ExAblate Neuro device to treat essential tremor.
July 10, 2016
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