Nephrodite's Holly™ Joins FDA's TAP Program: A Milestone in Dialysis Innovation

Congratulations to the Nephrodite team on HollyTM being selected into the FDA’s Total Product Life Cycle Advisory Program, another major milestone following FDA Breakthrough Device Designation.

TAP exists to help accelerate development and patient access for medical devices addressing critical unmet healthcare needs. For an investigational technology designed to rethink dialysis for people living with end-stage kidney disease, that mission could hardly be more fitting.

At Enlil, we’re proud to support teams like Nephrodite as they navigate the increasingly complex path from breakthrough innovation to regulatory readiness — where design controls, evidence, risk, traceability, and quality systems all need to move in step.

Huge congratulations to Nephrodite on this recognition and the important work ahead.

#MedTech #FDA #TAP #BreakthroughDevice #QualitySystems #RegulatoryStrategy