Regulatory: Page 60

Medicrea files 510(k) for 3D-printed spinal implant
By AuntMinnie.com staff writers
French implant developer Medicrea has filed a 510(k) submission for U.S. Food and Drug Administration clearance of its 3D-printed titanium patient-specific spinal implant.
January 8, 2017
Report on MACRA's impact on radiologists, and ACR advice
By Eric Barnes
A December 22 report in the Journal of the American College of Radiology details the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, along with the U.S. Centers for Medicare and Medicaid Services' 2016 implementation proposal, on radiologists.
December 28, 2016
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FDA video explains agency's role in 3D printing
By Eric Barnes
The U.S. Food and Drug Administration (FDA) has published an online consumer update and video explaining its role in the growing medical 3D printing segment. The agency's role boils down to the three R's: regulation, research, and resources.
December 28, 2016
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HRSA adopts new breast screening coverage guidelines
By AuntMinnie.com staff writers
The U.S. Health Resources and Services Administration (HRSA) has updated the Women's Preventive Services Guidelines, which now include new breast cancer screening coverage guidelines for average-risk women.
December 21, 2016
FDA clears Statlife's breast density assessment software
By AuntMinnie.com staff writers
Medical statistics and data mining firm Statlife has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its DenSeeMammo breast density assessment software.
December 20, 2016
Salutaris lands FDA OK for radionuclide brachytherapy
By AuntMinnie.com staff writers
Ophthalmic medical device developer Salutaris Medical Devices has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SMD-Sr90-DA radionuclide brachytherapy source.
December 19, 2016
Siemens gets FDA nod for Confidence RT Pro CT system
By AuntMinnie.com staff writers
Siemens Healthineers has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Somatom Confidence RT Pro, a CT scanner designed to aid radiation therapy (RT) planning.
December 19, 2016
FDA clears IRadimed's MRI-compatible pump
By AuntMinnie.com staff writers
MRI accessories developer IRadimed has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MRidium 3860+ MRI-compatible IV infusion pump system.
December 18, 2016
CMS declines to revisit CT colonography coverage
By Eric Barnes
In a stunning year-end setback for screening CT colonography, the U.S. Centers for Medicare and Medicaid Services (CMS) has turned down a request by advocates for CT colonography to reconsider its 2009 decision not to pay for the imaging-based colon cancer screening exam.
December 14, 2016
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Obama signs 21st Century Cures Act
By AuntMinnie.com staff writers
President Barack Obama signed the 21st Century Cures Act on Tuesday, enacting legislation that includes funding to combat the opioid epidemic, support medical research for cancer, and speed up the approval of medical devices and pharmaceuticals.
December 13, 2016
U.S. Senate passes 21st Century Cures Act
By AuntMinnie.com staff writers
The U.S. Senate has passed the 21st Century Cures Act by a 94-5 vote, bringing the legislation before President Barack Obama, who is expected to sign it.
December 7, 2016
U.S. House passes 21st Century Cures Act
By AuntMinnie.com staff writers
In a 392-26 vote, the U.S. House of Representatives on November 30 passed the 21st Century Cures Act, legislation that will invest $6.3 billion in public health initiatives.
December 1, 2016
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