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Regulatory: Page 291
CMS floats 10% cut for 2002 mammography reimbursement
By
AuntMinnie.com staff writers
The Ambulatory Patient Classification (APC) payment rate for screening mammography in 2002 will be $32.54, according to Centers for Medicare and Medicaid Services, a suggested 10% decrease from 2001.
August 20, 2001
Alliance closes in on Imavist clearance
By
AuntMinnie.com staff writers
Alliance Pharmaceutical has submitted follow-up documentation to the Food and Drug Administration regarding its Imavist echocardiography contrast agent, which is being co-developed with German pharmaceutical firm Schering.
August 19, 2001
FDA draft impact assessment of Federal Performance Standard for Diagnostic X-ray Systems
Issued August 15, 2001
The proposed amendments to the U.S. performance standard for diagnostic x-ray systems will add requirements for system features that manufacturers of fluoroscopic equipment must meet for newly manufactured systems.
August 14, 2001
FDA guidance on ensuring patient access to mammography records, part I of III
Issued August 14, 2001
When a facility closes, or otherwise ceases to perform mammography, its responsibility to provide patients access to their medical records remains.
August 13, 2001
Misonix gets approvals for Sonablate 500
By
AuntMinnie.com staff writers
Ultrasound developer Misonix's Focus Surgery affiliate has received regulatory approvals in Europe and Japan for its Sonablate 500 (SB-500) system, which performs ultrasound prostate imaging and treatment.
August 9, 2001
FDA clears Totoku monitor
By
AuntMinnie.com staff writers
Japanese display manufacturer Totoku has received clearance for a line of 3-megapixel LCD monitors for medical applications.
August 9, 2001
FDA accepts GE response to warning letter
By
AuntMinnie.com staff writers
GE Medical Systems appears to have satisfied the Food and Drug Administration's concerns regarding deficient procedures at the vendor's manufacturing facility in Buc, France, where GE manufactures the Senographe 2000D full-field digital mammography system.
August 9, 2001
Reimbursement drives huge growth in PET
By
Robert Bruce
The U.S. nuclear medicine market expanded 42% between 1999 and 2000, due mainly to the explosive growth of dedicated PET, according to a report by analysts at market research firm Frost & Sullivan of San Jose, CA.
August 6, 2001
Report: Mammography market to reach $567 million by 2007
By
AuntMinnie.com staff writers
The world x-ray mammography market reached $282.5 million in revenues in 2000, according to a new report from market research firm Frost & Sullivan.
August 5, 2001
Endoscopic imaging pill gets FDA clearance
By
AuntMinnie.com staff writers
Given Imaging of Israel has received Food and Drug Administration clearance for an ingestible pill capable of producing endoscopic images of the small intestine as it travels through the body.
August 2, 2001
Implant Sciences gets CE Mark for I-125 brachytherapy seeds
By
AuntMinnie.com staff writers
Radiation oncology and interventional cardiology firm Implant Sciences has received the CE Mark to market its I-Plant I-125 radioactive seeds for the treatment of prostate cancer in Europe.
August 1, 2001
Five-year review could be boon for breast imaging
By
AuntMinnie.com staff writers
Mammography exams in the U.S. may be up for another reimbursement boost, ranging from 15% for bilateral diagnostic exams to 18% for unilateral tests.
August 1, 2001
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