The government alleges that the company did not disclose serious health events in certain implantable defibrillators.
The 15-mm valve size is small enough to use in newborn patients to treat heart defects.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
The order settles anti-competitive charges related to vascular closure devices.
Certain chronic conditions, such as spinal disorders, could benefit from the use of medical devices versus long-term opioid treatment.
If exploited, unauthorized access to these devices could have dangerous consequences.
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The union of the two companies creates a market opportunity of nearly $30 billion.