PatenSee Receives FDA Breakthrough Device Designation for AI-Driven Hemodialysis Monitoring

PatenSee has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its non-contact vascular access monitoring technology, designed to improve care for patients undergoing hemodialysis. The AI-based optical system is intended to provide continuous, touch-free monitoring of vascular access sites, supporting early detection of complications such as stenosis.

Vascular access sites are critical in hemodialysis but are prone to complications that contribute to high morbidity, reduced quality of life, and increased healthcare costs. Current monitoring practices are labor-intensive and inconsistent. PatenSee’s platform is being developed to standardize monitoring in line with KDOQI guidelines, reduce clinical workload, and support earlier interventions.

The company is conducting a clinical trial in collaboration with Henry Ford Health to validate the system’s performance. PatenSee recently raised $2 million in seed funding from investors including Michigan Rise, Spark Capital, BRCC, Kalamazoo Forward Ventures, and Edge Medical Ventures to advance product development and clinical evaluation.