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The Centers for Medicare & Medicaid Services (CMS) has determined that using stenting with intracranial percutaneous transluminal angioplasty (PTA) -- a procedure for enlarging a narrowed artery -- is "reasonable and necessary" for treating patients with more than 50 percent cerebral artery stenosis, which is a narrowing of part of the carotid artery that supplies blood to the head and neck.
Growing economies, continued regulatory activity and increasing openness on the part of Asian governments to communicate with industry are creating "great opportunities" for devicemakers to shape developing Asian markets, according to Carolyn Albertson, director of international regulatory affairs for Abbott Laboratories.
Microsurgical instrument provider Synergetics "inadvertently overstated" the revenue figures in its recently filed motion for summary judgment in a patent dispute with laser manufacturer Iridex, Synergetics said in recent statement.
To be effective, the unique device identifier (UDI) system proposed by the FDA must work alongside upgrades in hospital IT systems that include the integration of electronic health records (EHRs), experts said at a recent meeting.
Spine device firm Kyphon is a good bet for investors, with four more quarters that are likely to come in above expectations, Lazard Capital Markets analyst Alexander Arrow said last week in a research note.
The device, drug and biologics industries could face billions in additional costs if the FDA requires risk analysis to be part of electronic recordkeeping regulations, an industry consultant says.
Although a recent study shows patients implanted with stents to treat clogged carotid arteries could be at greater risk for stroke or death than those treated with surgery, inconsistent results from a number of other clinical trials mean the jury is still out on the real benefits and risks of stenting.
The U.S. Court of Appeals for the Federal Circuit rendered a split decision Oct. 27 in a '259 urinary catheter patent case that originated from a lengthy contract dispute.
A group of 44 lawmakers wrote to HHS Secretary Michael Leavitt Oct. 31 asking him to step in and put the brakes on proposed cuts to the Medicare fee schedule for power mobility devices (PMDs) and accessories, which are due to go into effect Nov. 15.