Check out STAT’s exclusive breakthrough devices tracker.
The latest medical devices that have been awarded Breakthrough Status by the Food and Drug Administration cover a wide range of conditions, treating several cardiovascular and neurovascular conditions.
The FDA’s breakthrough device program is designed to accelerate the path to market for new, potentially life-saving products. It gives manufacturers better access to regulators and the ability to design more flexible clinical trials. All manufacturers have to do is prove to the FDA that their product can one day “more effectively” treat or diagnose a debilitating disease.
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