What is the significance of the FDA granting Breakthrough Device Designation to EoFlow's Automated Insulin Delivery system?
### EoFlow's Breakthrough in Diabetes Technology
The FDA has recently granted a Breakthrough Device Designation to a South Korean company, EoFlow, for its Automated Insulin Delivery (AID) system called EoPancreas. This designation is significant because it fast-tracks the regulatory review process, potentially bringing this innovative technology to market sooner. The EoPancreas system combines a tubeless insulin patch pump, known as EoPatch, with a continuous glucose monitor (CGM). This integrated system aims to simplify diabetes management by automatically adjusting insulin delivery based on real-time glucose levels.
#### Key Features of EoPancreas:
- **EoPatch**: A small, tubeless, and waterproof insulin pump that sticks to the skin and lasts for 72 hours. It holds up to 200 units of insulin and is designed to minimize clogging.
- **Smartphone Control**: The system can be controlled via a special handheld device or potentially through a smartphone app, making it user-friendly.
- **CGM Sensor**: The system uses a CGM sensor from POCTech, which is integrated into the patch pump to provide continuous glucose monitoring.
- **EoCloud**: A cloud-based software that uses AI algorithms to customize insulin delivery for each user.
EoFlow's breakthrough designation by the FDA is a promising step forward in diabetes care, offering a more convenient and efficient way to manage insulin delivery. The company aims to launch the product in the U.S. by 2021, pending further regulatory discussions and clinical trials.