FDA Breakthrough Device Designation

PyrAmes Inc. is proud to announce that the FDA has granted Breakthrough Device Designation (BDD) to Boppli™, which fills the unmet need of monitoring the blood pressure of critically ill infants when an invasive arterial catheter cannot be used due to the risk of complications and adverse effects.

The FDA’s BDD program is intended to facilitate development and expedite review of breakthrough medical device technologies. Breakthrough Device Designation has the potential to accelerate our plans to bring Boppli to market to improve medical care for babies in need of better blood pressure monitoring.