Regulatory: Page 75

CMS pushes back deadline for imaging decision support
By Erik L. Ridley
The U.S. Centers for Medicare and Medicaid Services (CMS) has postponed its January 1, 2017, deadline for physicians to start ordering advanced imaging studies with clinical decision-support software that is based on appropriate use criteria.
November 10, 2015
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FDA gives Volpara clearance for breast software
By AuntMinnie.com staff writers
Breast imaging software developer Volpara Solutions received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VolparaDensity breast imaging software.
November 8, 2015
CMS outlines rules for CT lung screening payments
By AuntMinnie.com staff writers
Starting January 4, Medicare contractors will accept claims for low-dose CT lung cancer screening retroactive to the U.S. Centers for Medicare and Medicaid Services (CMS) national coverage determination on February 5, 2015.
November 8, 2015
USPSTF posts final osteoporosis screening plan
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has posted a final research plan on screening to prevent osteoporotic fractures.
November 4, 2015
Medical groups rebel against meaningful use HIT program
By Erik L. Ridley
The American Medical Association and 110 other medical associations have asked U.S. lawmakers to intervene in the meaningful use program before physicians decide to no longer participate in the initiative, designed to spur the adoption of healthcare IT.
November 4, 2015
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InSightec submits PMA for ExAblate Neuro
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its ExAblate Neuro device for treating essential tremor.
October 21, 2015
SonaCare lands FDA nod for HIFU system
By AuntMinnie.com staff writers
High-intensity focused ultrasound (HIFU) developer SonaCare Medical has received U.S. Food and Drug Administration (FDA) clearance to market its Sonablate 450 system for the ablation of prostate tissue.
October 13, 2015
Penn. governor mandates insurance coverage of DBT
By AuntMinnie.com staff writers
Gov. Tom Wolf of Pennsylvania has announced that digital breast tomosynthesis (DBT), or 3D mammography, will be covered by insurance under existing state law and must be provided to Pennsylvania women at no cost.
October 13, 2015
Gamma Medica receives CE Mark for breast system
By AuntMinnie.com staff writers
Gamma Medica has received a CE Mark for the sale and distribution of its LumaGem molecular breast imaging (MBI) system within the European economic area.
October 12, 2015
Varian's Aria software certified for MU
By AuntMinnie.com staff writers
The Aria oncology information system software from Varian Medical Systems has been certified to demonstrate meaningful use (MU) as part of the U.S. government's healthcare IT stimulus program.
October 8, 2015
Colon cancer group criticizes USPSTF guidelines
By AuntMinnie.com staff writers
A colon cancer awareness group is criticizing this week's decision by the U.S. Preventive Services Task Force (USPSTF) to withhold its endorsement of two colon screening exams -- including CT colonography.
October 8, 2015
FDA OKs changes for InSightec's ExAblate
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has received U.S. Food and Drug Administration (FDA) clearance for a new version of its ExAblate device and a change in labeling.
October 8, 2015
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