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Regulatory: Page 295
FDA clears GE combo PET/CT scanner
By
AuntMinnie.com staff writers
GE Medical Systems of Waukesha, WI, has received FDA clearance for a hybrid scanner that combines PET and CT technology in the same gantry.
April 15, 2001
Contrast manufacturers await Medicare payment boost
By
Robert Bruce
The contrast media industry is poised to take advantage of new Medicare payment codes that go into effect in July. The resulting higher payments will partly offset a decline seen in some contrast media prices in recent years.
April 15, 2001
Where do PACS fit into FDA rules on device approvals?
(OTech) Until last year, the Food and Drug Administration regulated PACS devices as accessories to the imaging modalities with which they were used. In July 2000, the FDA changed course, however, issuing new guidelines for medical image management devices to recognize the significant expansion of their functionality.
April 11, 2001
HCFA expands covered uses for PET, but hedges on coincidence cameras
By
Eric Barnes
The U.S. Health Care Financing Administration (HCFA) on Tuesday expanded the list of circumstances under which Medicare will pay for PET scans. However, once again HCFA declined to expand coverage for the use of gamma cameras that use coincidence detection techniques for PET imaging.
April 11, 2001
NIH gets big boost in 2002 budget
By
AuntMinnie.com staff writers
The U.S. National Institutes of Health (NIH) was a big winner in the budget President Bush delivered to Congress on Monday. The proposed fiscal year 2002 budget earmarks nearly $23.1 billion for the NIH, an increase of $2.75 billion, or 13.5%, over fiscal 2001.
April 10, 2001
Misonix to deliver SonoReal
By
AuntMinnie.com staff writers
Misonix has received Food and Drug Administration 510(k) clearance for its SonoReal 3-D ultrasound probe, formerly known as Baby Face.
April 5, 2001
New U.S. bill recommends HIPAA-replacement surgery
By
Eric Barnes
Introduced March 27, the Medical Information Protection and Research Enhancement Act would nullify the HIPAA privacy rules issued by the Department of Health and Human Services last December. The bill's proponents say HHS should never have drafted the rules in the first place.
April 5, 2001
Theseus starts Apomate phase II trials
By
AuntMinnie.com staff writers
Theseus Imaging has initiated an FDA phase II clinical study of Apomate, an imaging agent designed to detect early patient response to anti-cancer treatment.
April 2, 2001
FDA clears Able Software’s 3D-Doctor
By
AuntMinnie.com staff writers
Lexington, MA-based Able Software has received FDA 510(k) clearance to market its 3D-Doctor software.
March 28, 2001
Schering gets approval for Resovist in Sweden
By
AuntMinnie.com staff writers
Swedish regulatory authorities have granted approval to Schering to sell its Resovist product, the first regulatory clearance for the MRI liver contrast agent.
March 27, 2001
Final guidance document on manufacturers' information disclosure for diagnostic x-ray systems
Issued March 27, 2001
Manufacturers are required to disclose information on assembly, installation, adjustment and testing (AIAT) to ensure that x-ray systems will meet U.S. performance standards. The information helps ensure compliance with performance standards that keep x-ray exposure levels as low as possible.
March 26, 2001
Mammography standards compliance draws FDA's ire
By
AuntMinnie.com staff writers
Ensuring compliance with mammography standards apparently takes up a big chunk of the Food and Drug Administration's time.
March 26, 2001
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