Regulatory: Page 107

House subcommittee mulls new approach to mobile app regulation
By Erik L. Ridley
The debate over how best to regulate mobile medical apps reached the halls of the U.S. Congress this week as representatives sparred over a proposed bill that could strip the U.S. Food and Drug Administration of its authority to regulate many types of app software.
November 19, 2013
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USPSTF to review breast screening guidelines
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has begun a review of its guidelines on breast cancer screening -- perhaps opening up a replay of its controversial 2009 decision rescinding support for screening younger women.
November 13, 2013
Patient groups support access to imaging
By AuntMinnie.com staff writers
Thirteen patient groups have submitted a letter urging the U.S. Congress to reject proposals to restrict patient access to medical imaging and radiation therapy technologies.
November 13, 2013
CMS approves RadSite for imaging accreditation
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved RadSite as the fourth accreditation organization under the Medicare Improvements for Patients and Providers Act.
November 10, 2013
Fuji SonoSite gets FDA nod for US scanner
By AuntMinnie.com staff writers
Fujifilm SonoSite has received U.S. Food and Drug Administration 510(k) clearance for its X-Porte Ultrasound Kiosk scanner.
November 7, 2013
Claron gets Health Canada nod for NilRead
By AuntMinnie.com staff writers
Advanced visualization and analysis firm Claron Technology has received Health Canada diagnostic approval for its NilRead zero-footprint medical image viewer.
November 7, 2013
Bill would restrict FDA app regulation
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration would be prohibited from regulating some types of mobile medical apps under legislation introduced in the U.S. House of Representatives late last month.
November 3, 2013
ACR cheers joint Senate, House proposal
By AuntMinnie.com staff writers
The American College of Radiology (ACR) said it applauds a new proposal introduced in the U.S. Congress to require ordering physicians to consult appropriateness criteria for advanced imaging services.
October 30, 2013
House members introduce breast density awareness bill
By AuntMinnie.com staff writers
Reps. Rosa DeLauro (D-CT) and Steve Israel (D-NY) have once again introduced breast density notification legislation in the U.S. House of Representatives.
October 30, 2013
CMS seeks MEDCAC nominees
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a request in the October 25 Federal Register for new members of an influential committee that helps CMS set reimbursement policy.
October 28, 2013
FDA approves GE's Vizamyl PET radiotracer for dementia
By Wayne Forrest
U.S. physicians looking to detect early signs of Alzheimer's disease now have a second tool in their arsenal with the U.S. Food and Drug Administration's approval of Vizamyl (flutemetamol F-18 injection), a radiopharmaceutical from GE Healthcare for use with PET imaging of the brain in adults being evaluated for Alzheimer's and dementia.
October 24, 2013
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Claron gets FDA clearance for NilRead
By AuntMinnie.com staff writers
Advanced visualization and analysis software firm Claron Technology has received U.S. Food and Drug Administration 510(k) clearance for its NilRead viewing software.
October 20, 2013
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