STAT has launched an exclusive tracker for medical devices that have been granted breakthrough status by the Food and Drug Administration (FDA). This designation is crucial as it enables a faster route to the market for groundbreaking and potentially lifesaving medical innovations. The tracker reveals a variety of devices receiving this status, with a notable number focusing on cardiovascular and neurovascular conditions.
The FDA’s Breakthrough Devices Program is specifically tailored to facilitate the development and expedited review process of novel devices that can more effectively treat or diagnose life-threatening or irreversibly debilitating diseases. For manufacturers, achieving this status is significant because it provides enhanced interaction with the regulator, the potential to design more adaptable clinical trials, and it simplifies the overall process towards market entry. Manufacturers aiming for this designation must demonstrate that their product has the potential to provide more effective treatment or diagnosis compared to existing options.
The content is a part of STAT’s premium service, STAT+, which provides in-depth analysis and reporting on the technology and innovations disrupting the healthcare sector. This service, described as award-winning journalism on transformative healthcare technology, offers various subscription plans, including individual and group options.
This exclusive content, accessible only to those with STAT+ subscriptions, offers insights into the latest breakthrough devices along with additional health technology analyses, aiming to keep subscribers informed on the latest advancements within medicine’s technological frontier.
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