Regulatory: Page 84

CMS issues final CT lung cancer screening approval
By Eric Barnes
In a major victory for individuals at high risk for lung cancer, the U.S. Centers for Medicare and Medicaid Services (CMS) has released its final decision memo on CT lung cancer screening. The current version contains several changes from last fall's draft decision memo, including an adjustment of screening age.
February 4, 2015
Nevro gets CE Mark for new MR-compatible labeling
By AuntMinnie.com staff writers
Medical device firm Nevro has received the European CE Mark for expanded MRI-conditioned labeling of its Senza implantable spinal cord stimulation system.
February 4, 2015
Feinstein, Ayotte introduce federal breast density bill
By AuntMinnie.com staff writers
Sen. Dianne Feinstein and Sen. Kelly Ayotte have introduced federal breast density notification legislation to the 114th U.S. Congress.
February 4, 2015
President's 2016 budget: More of the same for healthcare?
By Kate Madden Yee
The Obama administration has released its 2016 budget plan, and with respect to healthcare, it largely features proposals that were included in last year's budget. These include repealing the sustainable growth rate formula and eliminating the sequestration order that mandates cuts in payments to Medicare providers.
February 4, 2015
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Koning gets OK to sell 3D breast CT scanner in U.S.
By AuntMinnie.com staff writers
Breast CT developer Koning has received U.S. Food and Drug Administration approval for its breast CT scanner, including a biopsy bracket add-on.
February 3, 2015
Zonare receives Canadian clearance for Z.One Pro scanner
By AuntMinnie.com staff writers
Zonare Medical Systems has received regulatory clearance from Health Canada for its Z.One Pro ultrasound scanner.
January 29, 2015
CMS signals intent to change MU requirements
By AuntMinnie.com staff writers
Reacting to widespread concern over the burden of meeting current meaningful use (MU) reporting requirements, the U.S. Centers for Medicare and Medicaid Services (CMS) said it will soon propose a number of changes to the healthcare IT incentive program.
January 28, 2015
FDA gives Lantheus nod for Neurolite manufacturing
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has approved a supplemental new drug application for Neurolite, Lantheus Medical Imaging's technetium-based SPECT radiopharmaceutical agent.
January 28, 2015
EPA issues guidance on medical radiation protection
By Eric Barnes
The U.S. Environmental Protection Agency (EPA) on Monday issued new guidance on radiation protection during diagnostic and interventional x-ray procedures.
January 26, 2015
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HHS declares timeline for value-based payments
By AuntMinnie.com staff writers
U.S. Department of Health and Human Services (HHS) Secretary Sylvia Burwell has announced a timeline to shift the Medicare program toward paying healthcare providers based on quality rather than quantity of patient care.
January 26, 2015
FDA clears EOS' Micro Dose feature
By AuntMinnie.com staff writers
EOS Imaging has received U.S. Food and Drug Administration clearance for its Micro Dose feature for pediatric imaging.
January 25, 2015
NEC gets FDA nod for 3-MP monitor
By AuntMinnie.com staff writers
NEC Display Solutions of America has received U.S. Food and Drug Administration 510(k) clearance for its MultiSync MD210C3 LCD, a 3-megapixel (MP), 21-inch color display.
January 20, 2015
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