Patient Safety

Medtronic to Pay $51M to Settle DoJ Medical Device Probes

December 6, 2018 - Medtronic has agreed to pay a combined $51 million to resolve Department of Justice (DoJ) investigations into deceptive medical device marketing practices that could have endangered patient safety as well as kickback payments to hospitals.   The DoJ probes involve questionable conduct by two companies, ev3 and Covidien, before Medtronic acquired them. According to...

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Greater Medical Device Connectivity Prompts FDA Process Revision

by Fred Donovan

The FDA is updating its voluntary 510(k) approval process to take into account growing medical device connectivity and interoperability, the agency announced Nov. 26. The FDA explained that the 510(k)-approval process, which dates from...

Health IT infrastructure Gaps Create Patient Safety Risk

by Elizabeth O'Dowd

Healthcare organizations are faced with roadblocks when it comes to accurately retrieving complete patient data. Many of these obstacles can be traced back to an organization’s health IT infrastructure, interoperability, and how...


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