Safe and effective medical technologies can improve people’s lives only when they are accessible. As a physician and inventor, I am acutely aware that the more treatment options available to a provider, the better equipped they are to alleviate suffering and save lives.
In 2016, Congress sought to help enlarge the therapeutic toolkit with the passage of the
21st Century Cures Act
. It codified the Food and Drug Administration’s breakthrough program for medical devices to prioritize the review of new treatments that addressed critical gaps in patient care for serious or life-threatening conditions.
Breakthrough-designated technologies are required
to meet the same statutory standard of safety and efficacy as every other medical device under review by the agency. Breakthrough-designated devices are also offered additional FDA scientific experts, oversight, and, when scientifically appropriate, more flexible clinical trial structures to help accelerate the review of a technology.
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— Source: STAT News (https://www.statnews.com/2026/03/16/medicare-coverage-breakthrough-medical-technologies/)
