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Regulatory: Page 257
Medicare to expand carotid artery stenting coverage
By
AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) said it intends to extend Medicare coverage of carotid artery stenting to patients who are at high risk if they were to undergo carotid endarterectomy (CEA).
December 19, 2004
MammoSite gets HCPCS codes
By
AuntMinnie.com staff writers
Radiation therapy developer Proxima Therapeutics said that its MammoSite balloon catheter device has been assigned new Healthcare Common Procedure Coding System (HCPCS) codes by the Centers for Medicare and Medicaid Services (CMS) for placement of the product.
December 15, 2004
HIMSS releases device disclosure statement
By
AuntMinnie.com staff writers
The Healthcare Information and Management Systems Society (HIMSS) has published a Manufacturers Disclosure Statement for Medical Device Security, a form completed by manufacturers that healthcare providers can use to assess medical device security risks.
December 15, 2004
NEMA releases patching white paper
By
AuntMinnie.com staff writers
The joint NEMA/COCIR/JIRA Security and Privacy Committee (SPC) has issued a white paper on the patching of off-the-shelf software used in medical information systems.
December 15, 2004
Siemens DynaCT cleared by FDA
By
AuntMinnie.com staff writers
Siemens Medical Solutions has received FDA clearance for DynaCT, which allows its Axiom Artis FD systems to perform angiographic CT-like studies.
December 2, 2004
NEMA issues ethics code for imaging equipment makers
By
AuntMinnie.com staff writers
The National Electrical Manufacturers Association (NEMA) announced a new code of ethics for its members that make medical imaging or radiation therapy equipment.
December 2, 2004
Fischer cleared for interstitial breast brachytherapy
By
AuntMinnie.com staff writers
Fischer Imaging has received FDA clearance to use its MammoTest digital breast biopsy system for interstitial breast brachytherapy.
December 1, 2004
FDA clears GE's lung analysis software
By
AuntMinnie.com staff writers
The Food and Drug administration has cleared GE Healthcare's AdvantageALA, lung analysis software technology for CT used to evaluate lung nodules and other lesions.
November 29, 2004
Kodak gets FDA clearance for mammography CAD system
By
AuntMinnie.com staff writers
Eastman Kodak Health Imaging of Rochester, NY, has received FDA clearance for its mammography computer-aided detection (CAD) system, and will begin shipping immediately.
November 29, 2004
Intravascular ultrasound procedures assigned Medicare codes
By
AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, announced that the Centers for Medicare and Medicaid Services (CMS) has assigned new reimbursement codes that cover intravascular ultrasound (IVUS) procedures.
November 29, 2004
Toshiba cleared for cardiac CT software
By
AuntMinnie.com staff writers
The Food and Drug Administration has given 510(k) clearance to Toshiba America Medical Systems for its SurePlaque cardiac visualization software.
November 28, 2004
Bracco gets FDA nod for MultiHance
By
AuntMinnie.com staff writers
Contrast developer Bracco Diagnostics has received Food and Drug Administration clearance for its MultiHance gadolinium-based MR contrast agent.
November 23, 2004
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