Regulatory: Page 145

FDA releases guidance for device manufacturers
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has published a guidance document for medical device vendors that spells out how it considers the benefits and risks of certain medical devices during premarket review.
March 26, 2012
House repeals IPAB committee
By AuntMinnie.com staff writers
The U.S. House of Representatives has voted to repeal part of 2010's Affordable Care Act that established a committee to track whether Medicare spending is on target or over budget, according to House Ways and Means Committee Chair Rep. Dave Camp (R-MI).
March 21, 2012
NeuroLogica wins CE Mark for BodyTom CT scanner
By AuntMinnie.com staff writers
Portable scanner developer NeuroLogica has received CE Mark approval for BodyTom, its portable, full-body, multislice CT scanner. The CE Mark approval allows BodyTom to be sold in the European Union, the company said.
March 21, 2012
Matakina gets Canadian approval for Volpara
By AuntMinnie.com staff writers
Matakina International said it has received a medical device license by the Medical Devices Bureau of Health Canada to sell and market its Volpara breast imaging software in the country.
March 20, 2012
Terason, Soma get FDA nod for needle visualization
By AuntMinnie.com staff writers
Terason and Soma Access Systems have received U.S. Food and Drug Administration 510(k) clearance for a new transducer fitted with Soma's AxoTrack needle visualization technology.
March 19, 2012
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
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