
FDA breakthrough device designation
has received Breakthrough Device Designation from the FDA for our autonomous cardiac echo robot.
The FDA grants this designation to devices with the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating human diseases or conditions. It provides a pathway for closer collaboration with the FDA and prioritized review.
Recognition from the FDA reflects the potential of our technology to improve access to autonomous cardiac imaging for U.S. healthcare, improving access for rural areas and states where sonographer shortages exist.
Visit our product page to see our autonomous cardiac echo robot in action.