Regulatory: Page 92

Vital Images gets clearance for denoising software
By AuntMinnie.com staff writers
Advanced visualization firm Vital Images has received U.S. Food and Drug Administration (FDA) 510(k) clearance for image denoising software.
August 17, 2014
Siemens gets FDA nod for new iterative recon version
By AuntMinnie.com staff writers
Siemens Healthcare has received the U.S. Food and Drug Administration's 510(k) clearance for its third-generation advanced modeled iterative reconstruction (ADMIRE) algorithm, the company announced.
August 14, 2014
Health Canada OKs Hologic DEXA platform
By AuntMinnie.com staff writers
Hologic said it has received a medical license from Health Canada for its Horizon dual-energy x-ray absorptiometry (DEXA) imaging platform.
August 6, 2014
FDA clears NeoCoil's MRI audio system
By AuntMinnie.com staff writers
NeoCoil has received 510(k) clearance from the U.S. Food and Drug Administration for its new standalone wireless MRI audio system.
August 6, 2014
GE files 510(k) for PET/MR system
By AuntMinnie.com staff writers
GE Healthcare has filed for 510(k) clearance of its new whole-body Signa PET/MR scanner with the U.S. Food and Drug Administration.
August 3, 2014
Canada OKs Sterigenics' acquisition of Nordion
By AuntMinnie.com staff writers
Nordion said it has received approval to be acquired by sterilization services vendor Sterigenics under the Investment Canada Act.
August 3, 2014
Calif. AG puts pressure on for-profit college
By AuntMinnie.com staff writers
A California firm accused of running "phantom" programs for radiologic technologists will give prospective students more information on its plans to shut down most of its campuses in the state under an agreement with the state's attorney general (AG).
July 29, 2014
Report: ACR's PAC backs incumbents over rads
By AuntMinnie.com staff writers
The American College of Radiology's (ACR) political action committee, RADPAC, is spending more than $230,000 on support for incumbents in the Tennessee and Kansas Republican primary races -- rather than on radiologists who are challenging them for the posts, according to an article by the National Journal.
July 28, 2014
NEJM article seeks more FDA regulation of mHealth apps
By AuntMinnie.com staff writers
While mobile health (mHealth) apps have the potential to broaden healthcare access and control costs, more regulatory oversight is needed to ensure consumer confidence and safety, according to an article in the New England Journal of Medicine.
July 28, 2014
USPSTF posts plan for breast screening review
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has finalized its research plan for new recommendations for breast cancer screening as the group looks to update its controversial 2009 guidance.
July 23, 2014
FDA clears Philips' Visiq mobile US scanner
By AuntMinnie.com staff writers
Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for its Visiq mobile ultrasound scanner.
July 23, 2014
ACR urges CMS to cover breast tomosynthesis
By Kate Madden Yee
The American College of Radiology (ACR) is urging the U.S. Centers for Medicare and Medicaid Services (CMS) to reimburse providers for the extra cost of digital breast tomosynthesis. Women currently have to pay extra for tomosynthesis out of pocket, despite growing evidence of the technology's superiority over conventional digital mammography.
July 23, 2014
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