Regulatory: Page 84

NEJM: Are breast density notification laws actually helpful?
By Kate Madden Yee
Twenty-one states have passed laws requiring women to be notified if their breast tissue is dense on mammography. But are the laws actually helpful? It's unclear, according to a perspective article published in the February 12 issue of the New England Journal of Medicine.
February 11, 2015
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Medicatech USA gets FDA nod for 2 DR systems
By AuntMinnie.com staff writers
Medicatech USA has received 510(k) clearance from the U.S. Food and Drug Administration for two digital radiography (DR) systems.
February 10, 2015
FDA clears DR system from 20/20 Imaging
By AuntMinnie.com staff writers
20/20 Imaging has received U.S. Food and Drug Administration clearance for its HF PXS-710 digital radiography (DR) system.
February 9, 2015
Meridian's digital imager gets FDA nod
By AuntMinnie.com staff writers
Meridian Medical Systems has received U.S. Food and Drug Administration clearance to market its Monarch ultrahigh-definition Universal Digital Imager with wireless detector and automatic exposure detection.
February 9, 2015
FDA clears device for reducing stroke risk
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared a device designed to reduce stroke risk during stent and angioplasty procedures.
February 8, 2015
Sorin gets Japanese nod for MRI-compatible pacemaker
By AuntMinnie.com staff writers
The Sorin Group said it has received regulatory approval in Japan for a new MRI-compatible pacemaker.
February 8, 2015
FDA backs off oversight of image storage, communication devices
By AuntMinnie.com staff writers
In a new final guidance issued on Friday, the U.S. Food and Drug Administration confirmed it would no longer regulate technologies that receive, store, or display data from medical devices, including those used to store and communicate medical images.
February 8, 2015
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
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