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A federal appeals court reversed a lower court decision and revived a lawsuit between device manufacturer Stryker and a Brazilian insurance association that is accusing the company of paying kickbacks to doctors for using its devices. Read More
The agency said the quantity and quality of the available preclinical data was mixed, as some stents had full preclinical data, while others did not. Read More
The charges stem from allegations that the CEO and COO engaged in a multi-million dollar scheme to defraud investors and a separate scheme to defraud doctors and patients. Read More
The FDA issued a report to Congress on the results of mandatory training given to its premarket device review staff on applying the least burdensome requirements in product reviews. Read More
The FDA released draft guidance with recommendations for 510(k) submissions of guidewires intended for use in coronary, peripheral and neurovasculature procedures, including recommendations for biocompatibility tests. Read More