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
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
The FDA issued a Form 483 to Vital Connections, citing the medical device manufacturer on process and design validation procedures. 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
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