Regulatory: Page 264

NeoRx files IND for radiotherapy agent
By AuntMinnie.com staff writers
Radiotherapy pharmaceutical developer NeoRx has filed an investigational new drug (IND) application with the Food and Drug Administration for a phase II clinical study of its Skeletal Targeted Radiotherapy (STR) product in patients with breast cancer that has metastasized to the bone, according to the Seattle-based vendor.
July 5, 2004
Mallinckrodt, Palatin get FDA approval
By AuntMinnie.com staff writers
Contrast agent developer Palatin Technologies of Cranbury, NJ, and corporate partner Mallinckrodt have received approval from the Food and Drug Administration to market and distribute NeutroSpec.
July 5, 2004
Lodox gets CE Mark for Statscan
By AuntMinnie.com staff writers
Lodox Systems North America of South Lyon, MI, has received the CE Mark for its Statscan Critical Imaging System.
June 30, 2004
Radiology group pays $2.5 million to settle alleged Medicare fraud
By Tracie L. Thompson
A radiology group in southwest Florida has agreed to pay the U.S. government more than $2.53 million to settle allegations that it filed false Medicare claims -- allegations first lodged in a whistleblower lawsuit by the practice's former Medicare coding supervisor.
June 28, 2004
Planar gets 510(k) for flat-panel mammo display
By AuntMinnie.com staff writers
Monitor manufacturer Planar Systems has received 510(k) clearance from the Food and Drug Administration for a 5-megapixel flat-panel display designed for use with full-field digital mammography (FFDM) systems.
June 22, 2004
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
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