Regulatory: Page 83

Federal probe confirms scheduling woes at Phoenix VA
By Kate Madden Yee
A federal investigation has confirmed a number of shortcomings in radiology patient scheduling at a U.S. Department of Veterans Affairs (VA) hospital in Phoenix that was at the heart of a scandal last year over long patient waiting times.
February 26, 2015
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Fuji nets ONC certification for Synapse RIS
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received U.S. Office of the National Coordinator (ONC) HIT 2014 Edition Complete EHR certification for version 6.3.3 of its Synapse RIS.
February 23, 2015
U.S. probe clears Va. Veterans Affairs IR group
By AuntMinnie.com staff writers
The U.S. Office of Inspector General said it has cleared the Veterans Affairs Medical Center in Salem, VA, following allegations that its interventional radiology (IR) procedures were being performed by inadequately trained personnel.
February 19, 2015
FDA issues massive recall of GE MRI scanners
By Brian Casey
The U.S. Food and Drug Administration has ordered a recall of thousands of MRI scanners manufactured by GE Healthcare to correct a problem that could "result in life-threatening injuries" if magnet shutdown modules are disconnected, according to an FDA notice.
February 18, 2015
Canada approves Mevion proton therapy system
By AuntMinnie.com staff writers
Mevion Medical Systems has received clearance from the Canadian government for its Mevion S250 proton accelerator.
February 16, 2015
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
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