Regulatory: Page 265

U.S. Electronics gets 510(k)
By AuntMinnie.com staff writers
Display distributor U.S. Electronics has received Food and Drug Administration 510(k) marketing clearance for Totuku's ME511L five-megapixel monochrome LCD.
June 2, 2004
Rafael gets CE Mark
By AuntMinnie.com staff writers
Interventional device developer Rafael Medical Technologies has received European CE Mark approval for its SafeFlo retrievable vena cava filter for the prevention of pulmonary embolism.
June 2, 2004
Fischer obtains $4.25 million payment, CE Mark reinstated
By AuntMinnie.com staff writers
Women's imaging vendor Fischer Imaging of Denver said it has reached an agreement with Thermo Electron of Waltham, MA, to accelerate remaining payments owed the firm from a 2002 patent settlement into a single payment of $4.25 million.
June 2, 2004
iCAD gets FDA nod for Second Look 200
By AuntMinnie.com staff writers
Computer-aided detection developer iCAD has received Food and Drug Administration clearance for its Second Look 200 breast cancer CAD system.
June 2, 2004
Guidant gets CE Mark
By AuntMinnie.com staff writers
Interventional device firm Guidant said it has received CE Mark approval for Multi-Link Mini Vision, the company's cobalt chromium stent designed for treating coronary artery disease in small vessels. Guidant's Voyager coronary dilatation catheter has also been approved.
May 26, 2004
Legislation looms over offshore teleradiology services
By Tracie L. Thompson
The overnight coverage arrangements enjoyed by hundreds of U.S. radiology groups and hospitals may now be in jeopardy, as federal and state legislatures consider bills that would bar or hamstring the offshoring of protected healthcare information.
May 26, 2004
Toshiba gets FDA nod for new flat-panel detector
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received Food and Drug Administration clearance for a new cardiac flat-panel detector on its Infinix-i series of vascular imaging systems.
May 25, 2004
Boston Scientific touts Taxus VI clinical results
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has released nine-month results from its Taxus VI clinical trial at the 2004 Paris Course on Revascularization (PCR) this week in Paris.
May 25, 2004
Abbott debuts StarClose
By AuntMinnie.com staff writers
Interventional device developer Abbott Vascular Devices (AVD) unveiled its StarClose Vascular Closure System at the 2004 Paris Course on Revascularization (PCR) this week in Paris.
May 25, 2004
Ophthalmologists eye ultrasound
By Brian Casey
Ophthalmologists are breaking new ground in their use of ultrasound to diagnose disorders of the posterior eye.
May 25, 2004
High-tech rad therapy hospitals face lower reimbursement
By AuntMinnie.com staff writers
Healthcare facilities that offer the latest in radiation therapy are being hit with the lowest Medicare reimbursement rates, according to an analysis in the upcoming Oncology Issues.
May 24, 2004
Bracco clarifies SonoVue restrictions
By AuntMinnie.com staff writers
Italian contrast developer Bracco of Milan sought to clarify several points related to regulatory restrictions placed on its SonoVue ultrasound contrast agent by the European Agency for the Evaluation of Medicinal Products (EMEA).
May 23, 2004
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