Regulatory: Page 265

Summer brings news from AIUM, SNM shows
By Brian Casey
This week on AuntMinnie.com we're featuring daily reports from the annual meetings of the Society of Nuclear Medicine, underway in Philadelphia, and the American Institute of Ultrasound in Medicine, now going on in Phoenix.
June 22, 2004
CMS to reimburse PET for Alzheimer's
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) reported that it intends to expand Medicare coverage of PET to include some Medicare beneficiaries with suspected Alzheimer's disease.
June 15, 2004
Barco mammo display gets FDA OK
By AuntMinnie.com staff writers
Monitor provider Barco has received U.S. Food and Drug Administration 510(k) marketing clearance for its cathode ray tube-based MGD 521M dedicated mammography display.
June 14, 2004
A novel solution to malpractice insurance woes
By Brian Casey
June 8, 2004
Final 510(k) decisions for May 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for May 2004:
June 7, 2004
Malpractice crisis prompts look at self-insurance
By Brian Casey
SAN DIEGO - Shell-shocked by the high cost of malpractice insurance premiums? You might want to consider self-insuring your practice, says a man who created such a plan, and described the experience to attendees of the Radiology Business Management Association (RBMA) meeting.
June 7, 2004
Schering submits MS-325 for EU approval
By AuntMinnie.com staff writers
German pharmaceutical firm Schering has submitted Epix Medical's MS-325 intravenous blood pool MR angiography contrast agent for marketing approval in the European Union.
June 6, 2004
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
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