We’re very proud to share that Scinvivo’s Lumante Imaging system has received FDA Breakthrough Device Designation!
The Breakthrough Devices Program is a voluntary program for medical devices that provide for more effective treatment or diagnosis of life-threatening diseases or conditions, and its intention is to provide patients and health care providers with timely access to medical devices.
Scinvivo’s Lumante imaging platform is intended for realtime, minimally invasive visualization and local staging of bladder cancer.
More information on the breakthrough devices program can be found at the FDA website:
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program