Regulatory: Page 50

MITA hails bill to suspend medical device tax
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) said it supports a new bill in the U.S. House of Representatives that would suspend the medical device tax.
December 12, 2017
FDA releases report on patient-reported outcomes
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released its first report on patient-reported outcomes from the use of medical devices.
December 12, 2017
FDA issues new draft guidance for medical software, CDS
By Erik L. Ridley
The U.S. Food and Drug Administration (FDA) has released new draft guidance documents for medical software and clinical decision-support (CDS) software in response to regulatory changes mandated by the 21st Century Cures Act.
December 10, 2017
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Japan requires changes in GBCA labeling information
By Wayne Forrest
Japan's Ministry of Health, Labor, and Welfare is following suit with regulatory agencies in the U.S. and Europe in asking four makers of gadolinium-based contrast agents (GBCAs) for MRI scans to revise warning text on their product labeling information.
December 7, 2017
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FDA recognizes radiotherapy readiness standard
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has recognized the RT-2 Radiotherapy Readiness Check standard published earlier this year by the Association for the Advancement of Medical Instrumentation.
December 5, 2017
FDA releases guidance on 3D printing of medical products
By Abraham Kim
The U.S. Food and Drug Administration (FDA) on December 4 released a new set of recommendations for creating medical products using 3D printers. The guidance details the agency's stance on device design, testing, and quality system requirements.
December 3, 2017
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FDA provides update of Cures Act
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has provided an update on the 21st Century Cures Act.
November 29, 2017
FDA issues guidance on lowering pediatric x-ray dose
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) published a final guidance on November 28 regarding pediatric x-rays, recommending dose reductions in new x-ray devices.
November 27, 2017
Bipartisan breast density bill introduced in Congress
By AuntMinnie.com staff writers
A bipartisan bill that would standardize communication to women regarding whether they have dense breast tissue on mammography was introduced in both the U.S. House of Representatives and the U.S. Senate on October 25.
November 9, 2017
USPSTF to review osteoporosis screening
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) is seeking comment on a draft recommendation for osteoporosis screening with dual-energy x-ray absorptiometry.
November 8, 2017
ASTRO chair set to testify on Medicare payment reform
By AuntMinnie.com staff writers
American Society for Radiation Oncology (ASTRO) Chair Dr. Brian Kavanagh will discuss Medicare payment reform on November 8 before the U.S. House of Representatives' Energy and Commerce Committee's subcommittee on health.
November 6, 2017
Mixed results for radiology in final 2018 Hospital OPPS
By Kate Madden Yee
The U.S. Centers for Medicare and Medicaid Services has released its final rule for the 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System -- and there's both good and bad news for radiology.
November 5, 2017
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