Portal Diabetes, Inc. has received Breakthrough Device Designation from the U.S. FDA for its implantable insulin pump system, the Portal Pump.

The designation gives the company priority FDA interaction during development and review and makes the device eligible for Medicare’s Transitional Coverage for Emerging Technologies pathway, which could speed reimbursement if approved.

Portal is developing a fully implantable, closed-loop system that delivers insulin into the intraperitoneal cavity, which is the same area a healthy pancreas releases insulin. This approach allows insulin to act 4 to 5 times faster than traditional subcutaneous delivery and more closely match natural physiology.

In parallel, the company has launched a Phase 1 study of its proprietary “Portal Insulin,” a temperature-stable, concentrated insulin designed specifically for intraperitoneal use. Under an Investigational New Drug authorization, the first two patients in San Diego, California, have received injections into the intraperitoneal space.

Both the Portal Pump and Portal Insulin are investigational and not yet commercially available, with larger trials expected to begin in late 2027. We recently spoke with Portal Diabetes on our podcast about how the pump works and the what’s next as research and development move forward. Portal isn’t the first to work on an implantable — Medtronic developed its own implantable in the 1980s and nearly 400 people used it, with some still using it today.

Would you consider an implantable insulin pump if it meant faster insulin action and fewer daily decisions? Leave your thoughts in the comments below.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.