We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Participants in the pilot program agreed to provide information on how they develop, test and maintain their software products and on their quality management systems. They also committed to being available for site visits from agency officials. Read More
“The improper influence Stryker allegedly brought to bear increased the cost of devices as well as the number of devices implanted and surgeries performed,” which association members had to pay for, court documents said. Read More
The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health and safety. Read More
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The FDA released draft guidance with recommendations for 510(k) submissions of guidewires intended for use in coronary, peripheral and neurovasculature procedures, including recommendations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