Regulatory: Page 144

U.S. marshals seize contaminated ultrasound gel
By AuntMinnie.com staff writers
Acting at the request of the U.S. Food and Drug Administration, U.S. marshals have seized Other-Sonic generic ultrasound transmission gel from manufacturer Pharmaceutical Innovations in Newark, NJ, after FDA analysis discovered dangerous bacteria in product samples.
April 17, 2012
GE gets FDA nod for Q.Freeze PET/CT software
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for its Q.Freeze PET/CT quantitative imaging software.
April 17, 2012
Novian Health begins breast cancer trial
By AuntMinnie.com staff writers
Novian Health has begun a multicenter clinical trial on the use of its Novilase interstitial laser therapy (ILT) for the destruction of malignant breast tumors, the company said.
April 11, 2012
CMS announces first ACOs
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has announced the first 27 accountable care organizations (ACOs) to participate in its Medicare Shared Saving Program.
April 11, 2012
FDA panel recommends approval for ABUS for breast screening
By Erik L. Ridley
The first U.S. Food and Drug Administration (FDA) approval for an automated breast ultrasound (ABUS) system in breast cancer screening applications moved closer to reality after an FDA panel voted to recommend approval of U-Systems' somo.v system for use in screening of women with dense breasts.
April 10, 2012
AHRQ seeks new USPSTF members
By AuntMinnie.com staff writers
The U.S. Agency for Healthcare Research and Quality (AHRQ) is taking nominations for new members to the U.S. Preventive Services Task Force (USPSTF).
April 10, 2012
Dental x-rays linked to brain tumors; FDA to review ABUS device
By Brian Casey
April 9, 2012
U-Systems awaits FDA panel review of ABUS for screening
By Erik L. Ridley
Ultrasound developer U-Systems hopes Wednesday's meeting of the U.S. Food and Drug Administration's Radiological Devices Panel will be a big step forward in its bid to be the first vendor to receive approval to market an automated breast ultrasound (ABUS) system for screening applications in women with dense breasts.
April 9, 2012
HHS proposes to postpone ICD-10 compliance by 12 months
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) today announced a proposed rule that would extend the compliance for adopting ICD-10 diagnosis and procedure codes until October 1, 2014, a full year beyond the current deadline.
April 8, 2012
Ga. radiation therapy practice to settle $3.8M fraud claim
By Cynthia E. Keen
The U.S. Department of Justice has announced that a radiation oncology practice in Georgia has agreed to pay $3.8 million to settle allegations that it violated the False Claims Act by allegedly overbilling for claims submitted to Medicare.
April 4, 2012
Imaging aims to tweak Calif. radiation law before it takes effect
By Eric Barnes
Imaging advocates are beginning their final push for changes in the California radiation protection law -- hoping to have everything settled before the law takes effect in July. The language fixes were amended and passed by the Assembly last week and sent on to the state Senate.
April 1, 2012
2012 03 30 12 52 36 628 California State Capitol 70
Calif. senator reintroduces dense-breast screening bill
By AuntMinnie.com staff writers
California state Sen. Joe Simitian is reintroducing a bill to notify women with dense breast tissue detected at mammography that they might want to explore additional screening options.
March 29, 2012
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