We're excited to announce that Perceptive Medical has received a Breakthrough Device Designation from the United Stated Food and Drug Administration. The FDA describes the BDD program as follows:
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
This designation will give Perceptive Medical opportunities to interact with the FDA through several additional programs to address topics that arise during premarket review; it will also allow us to have prioritized review for future submissions.
We are very grateful to have been granted this designation and believe it will facilitate our regulatory steps as we move towards marketing approval!