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Sen. Mike Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, announced July 28 he has closed a yearlong investigation into the FDA's advisory committee review of silicone breast implants.
Device and diagnostics makers can avoid being blamed for inflated healthcare costs by focusing on competitive strategies that add value to their products, experts say.
TyRx Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for PIVIT AB, a new surgical mesh product coated with a proprietary bioresorbable polymer containing the antimicrobial agents rifampin and minocycline.
Abbott announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its i-STAT BNP cartridge, a new point of care diagnostic test used to quickly assess the level of BNP (brain naturietic peptide) in patients in emergency rooms, heart failure clinics and observation units, laboratories and other critical care settings.
Steris Corporation announced that the United States Food and Drug Administration (FDA) has given the Company clearance to market its Reliance Endoscope Processing System (EPS).
Cepheid, a broad-based molecular diagnostics company, announced the 510(k) clearance of its first clinical molecular diagnostic product for the Unites States market.
Biomet announced that the scope of the antitrust investigation, previously disclosed by the Company on June 26, 2006, has currently been narrowed to a specific geographic region and specific product lines.
St. Jude Medical and Boston Scientific have entered into an agreement that resolves four previously disclosed patent cases, the firms announced July 31 in a joint statement posted on the St. Jude website.