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When the Wisconsin Physician Service (WPS) announced last month it will provide reimbursement for the Pillar procedure in an office setting, device firm Restore Medical's prospects got a little brighter, RBC Capital Markets analyst Phil Nalbone said in a recent research note.
While voicing their support for the FDA's all-electronic submission system proposal, industry leaders are warning that the agency has a lot to consider before going forward.
In observance of the holiday season, FDAnews Device Daily Bulletin will not be published Monday, Jan. 1. The next issue will be published Tuesday, Jan. 2.
In a 2007 device industry overview, Merrill Lynch Research forecasts a rebound in the market for "high-power" devices, which treat heart failure or sudden cardiac death, Merrill Lynch Research analyst Katherine Owen said.
California-based Sutura has filed a patent infringement lawsuit against Abbott Laboratories and its Perclose unit in the U.S. District Court for the Eastern District of Texas.
A new draft guidance issued by Health Canada walks manufacturers through the various requirements of obtaining a license to market a Class II, III or IV medical device.
The National Advertising Division (NAD) of the Council of Better Business Bureaus has referred advertising for the GraftJacket, a wound-care product, to the FTC and the FDA for review, according to NAD.