Regulatory: Page 142

MITA lauds OMB's support of medical device deal
By AuntMinnie.com staff writers
The Office of Management and Budget (OMB) has cleared a commitment letter between the medical device industry and the U.S. Food and Drug Administration, bringing the reauthorization of the medical device user fee program closer to implementation, the Medical Imaging and Technology Alliance (MITA) said.
March 15, 2012
CMS tool may overestimate number of unnecessary brain CTs
By Cynthia E. Keen
There may be flaws in a new statistical tool developed by the U.S. Centers for Medicare and Medicaid Services (CMS) that's designed to measure how often hospitals perform appropriate brain CT studies on emergency patients presenting with headaches, according to an article published online February 24 in Annals of Emergency Medicine.
March 15, 2012
MedPAC proposes Medicare benefit reform
By AuntMinnie.com staff writers
In a meeting on March 8, the Medicare Payment Advisory Commission (MedPAC) recommended that the U.S. Congress direct the Secretary of Health and Human Services to develop a new fee-for-service benefit design that could include higher patient co-payments for advanced diagnostic imaging services.
March 11, 2012
FDA OKs new silicone gel-filled breast implant
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has approved a silicone gel-filled breast implant manufactured by Sientra for breast size augmentation in women at least 22 years old and to rebuild breast tissue in women of any age.
March 8, 2012
Bill would require Medicare to pay for virtual colonoscopy
By AuntMinnie.com staff writers
A bill has been introduced in the U.S. House of Representatives that would require Medicare payments for virtual colonoscopy screening.
March 8, 2012
Alaska introduces radiography licensure bill
By AuntMinnie.com staff writers
State Rep. Chris Tuck (D-Anchorage) has introduced a bill in the Alaska Legislature that would require individuals to secure a license before performing radiography, radiation therapy, or nuclear medicine procedures.
March 6, 2012
Data workgroup launches Health IT Track
By AuntMinnie.com staff writers
The Workgroup for Electronic Data Interchange announced the launch of its Health IT Track, a federal and state regulatory and legislative tracking service, on March 1, 2012.
March 5, 2012
UE LifeSciences gets FDA OK for infrared device
By AuntMinnie.com staff writers
Breast thermography vendor UE LifeSciences has received 510(k) clearance from the U.S. Food and Drug Administration for its NoTouch BreastScan device.
March 5, 2012
CMS solicits imaging accreditation applicants
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a notice in the Federal Register inviting independent accreditation organizations to apply to become a CMS-designated organization for accrediting suppliers furnishing the technical component of advanced diagnostic imaging services.
March 4, 2012
ACR collects over 200 cosponsors for HR 3269
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has amassed 202 bipartisan cosponsors for HR 3269, the Diagnostic Imaging Services Access Protection Act.
March 4, 2012
Health Canada approves Carestream mobile x-ray
By AuntMinnie.com staff writers
Health Canada has issued a medical device license for Carestream Health's DRX-Revolution mobile x-ray system.
February 29, 2012
Varian nets FDA OK for transponder
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for a surface beacon transponder for its Varian Calypso system as a real-time tracking device to monitor motion during radiotherapy for indications anywhere in the body.
February 27, 2012
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