Regulatory: Page 140

Senate bill would halt multiple-scan payment cuts
By AuntMinnie.com staff writers
U.S. Sens. Ben Cardin (D-MD) and David Vitter (R-LA) introduced legislation on April 25 that would halt a cut in Medicare reimbursement for multiple imaging studies performed on the same patient on the same day.
April 26, 2012
FDA clears Toshiba's AIDR 3D CT reconstruction
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received clearance from the U.S. Food and Drug Administration for its newest dose reduction technology, adaptive iterative dose reduction (AIDR) 3D.
April 24, 2012
FDA clears GE's cardiac US system
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared GE Healthcare's latest version of its Vivid E9 cardiovascular ultrasound system.
April 24, 2012
CurveBeam nets FDA nod for extremity CT
By AuntMinnie.com staff writers
Orthopedic and podiatric imaging technology developer CurveBeam has received U.S. Food and Drug Administration 510(k) clearance for its pedCAT 3D foot and ankle CT scanner.
April 23, 2012
TomTec gets FDA nod for cardiac MR software
By AuntMinnie.com staff writers
Imaging software developer TomTec Imaging Systems has received 501(k) clearance from the U.S. Food and Drug Administration for its new 2D Cardiac Performance Analysis MR software.
April 22, 2012
FDA panel declines to ease rules on breast transilluminators
By Kate Madden Yee
A breast imaging technology called breast transillumination will continue to be regulated under the U.S. Food and Drug Administration's most stringent category for medical devices after an FDA panel declined a U.K. company's petition to relax its rules.
April 19, 2012
2012 04 19 14 56 51 970 Fda Transillumination Thumb
Carestream gets FDA nod for DRX-Revolution
By AuntMinnie.com staff writers
Carestream Health has received U.S. Food and Drug Administration clearance for its DRX-Revolution mobile digital radiography system.
April 18, 2012
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
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