Regulatory: Page 296

Deus nears approval for lung cancer detection unit
By AuntMinnie.com staff writers
Computer-aided detection developer Deus Technologies may be close to Food and Drug Administration approval for its RapidScreen RS-2000 lung cancer detection device.
March 26, 2001
ATSP report examines U.S. teleradiology services
By AuntMinnie.com staff writers
The Association of Telehealth Service Providers (ATSP) will soon release its 2001 report on radiology facilities and the market for teleradiology services.
March 26, 2001
CARE bill reintroduced with bipartisan support
Advocates of accreditation standards for radiologic technologists breathed a sigh of relief last week when the Consumer Assurance of Radiologic Excellence (CARE) bill was reintroduced in the U.S. House of Representatives. A lack of uniform standards puts patients at risk, they say.
March 22, 2001
Magna-Lab submits 510(k) for Cardiac View surface coil
By AuntMinnie.com staff writers
Niche MRI developer Magna-Lab has submitted a 510(k) application to the Food and Drug Administration for its Cardiac View surface coil.
March 19, 2001
U.S. senators introduce bill to raise screening mammography payments 30%
By Brian Casey
Saying they want to head off a crisis in women's access to mammograms, two U.S. senators have introduced legislation to raise the reimbursement rate Medicare pays for screening mammography. The bill would boost payments from $69 to $90, an increase of 30%.
March 18, 2001
Final 510(k) approvals for February 2001
Updated March 16, 2001
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 February 2001.
March 15, 2001
Fischer files PMA for SenoScan full-field digital mammography system
By Erik L. Ridley
The U.S. digital mammography market may soon gain another participant. Fischer Imaging has submitted a premarket approval (PMA) application to the Food and Drug Administration for the company's SenoScan full-field digital mammography system.
March 14, 2001
Consumer groups battle healthcare industry over HIPAA privacy rules
By Robert Bruce
A behind-the-scenes tug-of-war is underway over whether the final privacy regulations established by the Health Insurance Portability and Accountability Act (HIPAA) will be implemented -- or whether various healthcare industry segments will succeed in rewriting the rule's provisions.
March 11, 2001
Film-screen mammography remains gold standard, IOM says
By Erik L. Ridley
New breast imaging techniques such as full-field digital mammography (FFDM) may show promise, but film-screen mammography (FSM) remains the gold standard for now, according to a report issued today by the Institute of Medicine (IOM) and the National Research Council of the National Academies.
March 7, 2001
The American College of Radiology Statement On IOM Report on Mammography and Beyond
The American College of Radiology agrees with the Institute of Medicine (IOM) National Academy of Science’s conclusion that film mammography is still the "gold standard" for early detection of breast cancer and that new technologies also show promise.
March 7, 2001
Recommendations from the IOM’s Technologies for the Early Detection of Breast Cancer committee
March 7, 2001
Final PMA approvals for February 2001
Issued March 6, 2001
 Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for February 2001.
March 5, 2001
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