Regulatory: Page 276

EPMedSystems files 510(k) for ultrasound catheter system
By AuntMinnie.com staff writers
Electrophysiology equipment developer EPMedSystems has submitted a 510(k) filing with the U.S. Food and Drug Administration for regulatory approval of its ViewMate intracardiac ultrasound catheter system.
April 3, 2003
GE, Instrumentarium deal may be in trouble
By AuntMinnie.com staff writers
GE Medical Systems has extended its $2.06 billion offer to buy Finnish healthcare technology firm Instrumentarium until August 29, as the EU’s Competition Commission begins a formal four-month investigation of the deal.
April 3, 2003
U.S. standardizes electronic information exchange
By AuntMinnie.com staff writers
The U.S. Departments of Health and Human Services (HHS), Defense (DoD), and Veterans Affairs (VA) have released the first set of uniform standards for the electronic exchange of clinical health information, to be adopted across the U.S. government.
March 31, 2003
Boston Scientific starts Taxus V clinical trials
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has started a new clinical trial to evaluate the use of a slow-release formulation of its Taxus paclitaxel-eluting coronary stent system in high-risk patients.
March 17, 2003
Given Imaging feature gets FDA approval
By AuntMinnie.com staff writers
Video-capsule manufacturer Given Imaging has received Food and Drug Administration clearance for a new feature in its M2A capsule endoscopy system, the Suspected Blood Indicator.
March 3, 2003
Lodox debuts full-body DR unit
By AuntMinnie.com staff writers
Lodox Systems North America has unveiled Statscan, a flexible-format digital radiography system designed for trauma centers and emergency rooms.
March 2, 2003
CMS to determine additional PET reimbursement
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has published a new tracking sheet announcing the acceptance for five formal requests for a National Coverage Determination (NCD) on the use of FDG-PET imaging for brain, cervical, pancreatic, small cell lung, and testicular cancers.
February 27, 2003
Add legal exposure to CT screening risks
By Brian Casey
You’ve heard about the potential risks of radiation exposure in CT screening exams. But what about the risks of legal exposure for those who provide the service? A new article in our CT Digital Community explores the legal side of screening asymptomatic patients.
February 27, 2003
U.S. increases CAD reimbursement
By AuntMinnie.com staff writers
Beginning March 1, 2003, the U.S. Centers for Medicare and Medicaid Services (CMS) will raise the reimbursement levels for the use of computer-aided detection (CAD) in mammography.
February 26, 2003
Pie gets FDA clearance for ob/gyn portable ultrasound
By AuntMinnie.com staff writers
The FDA has cleared the Picus 3.0 ultrasound scanner made by Dutch-based Pie Medical.
February 26, 2003
Novoste modifies clinical trial
By AuntMinnie.com staff writers
Vascular brachytherapy firm Novoste has received Food and Drug Administration approval for an investigational device exemption supplement.
February 25, 2003
Physician groups navigate a rocky road to PET reimbursement
By Jonathan S. Batchelor
The Centers for Medicare and Medicaid Services (CMS) will update its policies for PET reimbursement next week. Ruth Tesar, executive director of Northern California PET Imaging in Sacramento, traces PET imaging's complicated reimbursement history.
February 25, 2003
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