Regulatory: Page 217

CMS and physician self-referral: More bark than bite?
By Wayne Forrest
WASHINGTON, DC - Is the Centers for Medicare and Medicaid Services (CMS) more talk than substance on the issue of physicians making money from self-referrals and related imaging interpretation services? Attorney Thomas Greeson offered his perspectives on the CMS during a presentation on the opening day of the American Roentgen Ray Society annual meeting.
April 13, 2008
Orthocrat nets CE Mark
By AuntMinnie.com staff writers
Orthopedic template and surgical planning provider Orthocrat has received the European CE Mark for its TraumaCad software.
April 8, 2008
3mensio nets CE Mark for workstation
By AuntMinnie.com staff writers
Advanced visualization developer 3mensio Medical Imaging of Bilthoven, Netherlands, has received the CE Mark Class IIa for its 3surgery vascular imaging workstation.
April 7, 2008
FDA OKs iCAD SecondLook with Fuji FCRm
By AuntMinnie.com staff writers
iCAD of Hudson, NH, has received U.S. Food and Drug Administration (FDA) clearance to market its SecondLook Digital computer-aided detection (CAD) product with Fujifilm Medical Systems USA's Computed Radiography for Mammography (FCRm) system.
April 6, 2008
Imaging3 gets FDA IDE
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 has received U.S. Food and Drug Administration (FDA) clearance to distribute its Dominion volumetric imaging scanner under the FDA's investigational device exemption (IDE) regulations.
April 1, 2008
Mindray gets clearance for ultrasound system
By AuntMinnie.com staff writers
Medical device manufacturer Mindray Medical International has received U.S. Food and Drug Administration clearance for its M5 portable ultrasound scanner.
March 31, 2008
Toshiba nets FDA OK for prospective CT
By AuntMinnie.com staff writers
Toshiba America Medical Systems of Tustin, CA, has received U.S. Food and Drug Administration (FDA) clearance for two new CT clinical applications designed to reduce contrast and radiation dosage and enhance workflow, including a prospective CT scanning protocol.
March 27, 2008
Cook begins Reform clinical trial
By AuntMinnie.com staff writers
Interventional technology firm Cook Medical has launched the Reform clinical trial, designed to evaluate its Formula balloon expandable stent for treating renal artery stenosis.
March 19, 2008
FDA clears Xoft brachytherapy device
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared new indications for a brachytherapy device from Xoft of Sunnyvale, CA.
March 16, 2008
FDA clears software for liver, gallbladder diagnosis
By AuntMinnie.com staff writers
A software package designed to assist with the clinical diagnosis of liver and gallbladder diseases has been cleared by the U.S. Food and Drug Administration (FDA).
March 11, 2008
Siemens adds Definition applications
By AuntMinnie.com staff writers
Siemens Medical Solutions has received U.S. Food and Drug Administration 510(k) clearance for four applications on its Somatom Definition dual-source CT scanner.
March 10, 2008
CAD vendors hope FDA hearings will clear approval bottleneck
By Cynthia E. Keen
The U.S. Food and Drug Administration (FDA) today began a two-day set of hearings that could result in major changes to the way the agency regulates computer-aided detection (CAD) technology. Industry experts are hoping the hearings will clear up a logjam of delayed regulatory applications for CAD software that has been building since last year.
March 3, 2008
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