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A federal grand jury indicted Theranos CEO Elizabeth Holmes and COO Ramesh Balwani on two counts of conspiracy to commit wire fraud and nine counts of fraud. Read More
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
Women implanted with the device may continue to use the device, and preventive removal is not necessary for women not presenting any symptoms, FAMHP said. Read More
The bone cement’s expanded indication now allows it to treat fractures caused by osteoporosis, cancer or benign lesions by using a cementoplasty procedure. Read More
The FDA cited Arcamed for deficiencies in its CAPA procedures and issues with its quality audit and employee training procedures after a February/March inspection of the company’s Indianapolis facility. Read More
The FDA slapped Gendron with a Form 483 for shoddy complaint handling and deficient MDR procedures, as well as issues with its internal quality auditing. Read More