Medtronic ($MDT) CEO Bill Hawkins says his company is still waiting for the FDA to lift a warning letter that is blocking approval for key heart-rhythm devices, the Wall Street Journal reports.
Hawkins spoke on the sidelines of the Wall Street Journal CEO Council conference, adding that his company is in constant dialogue with the regulator. However, he doesn't know precisely where the FDA is in the process." The agency has completed a reinspection of the Minnesota site, and Medtronic is awaiting a response.
According to the WSJ, Medtronic is waiting in the U.S. for the ability to sell pacemakers designed to work safely in MRI scanners; however, the company can't launch these products here until it resolves the warning letter the FDA issued last year for problems it found at the company's heart-rhythm headquarters in Minnesota.
The new heart-rhythm devices are among dozens of products Medtronic highlighted at an investor meeting in June, when the Minneapolis-based company also said it plans to spend up to $10 billion on research and development in the next five years. That outlook framed Medtronic's plans to grow from within rather than relying on large-scale acquisitions.
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