Diagnostic companies are hustling to increase availability of testing.
The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.
The device can be implanted in babies weighing as little as two pounds.
The device is indicated for patients who have advanced heart failure and are not eligible for a transplant.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
The issue involves problems removing the balloon sheath during cardiac procedures.
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The union of the two companies creates a market opportunity of nearly $30 billion.