PatenSee Receives FDA Breakthrough Device Designation

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for PatenSee’s non-contact vascular access (VA) management technology designed for patients undergoing hemodialysis. This designation provides a streamlined regulatory process to accelerate the development and adoption of PatenSee’s platform in dialysis clinics.

PatenSee’s AI-driven optical monitoring system is being developed to enable comprehensive, touch-free physiological monitoring aligned with KDOQI guidelines, according to a press release.

“The technology is designed to alleviate the clinical burden of vascular access monitoring, support early detection of stenosis, and establish a new standard of care in dialysis management,” the release states.

“This recognition highlights PatenSee’s potential to transform dialysis care. We are committed to enabling patient-centered, interdisciplinary care to improve outcomes while reducing burden on the busy staff in dialysis clinics,” said Paul Neeb, CEO.

In hemodialysis, the VA site – where an artery and a vein are joined – is the patient’s lifeline. Routine monitoring is essential but time-consuming and often performed inconsistently. VA-related complications remain a leading cause of morbidity, impaired patient quality of life and substantial healthcare costs.

PatenSee’s breakthrough technology has the potential to help clinicians identify VA-related complications earlier than current standard of care, enabling more timely intervention when needed. By standardizing and streamlining monitoring, the clinical support system aims to improve patient outcomes while reducing financial burden for both providers and payers.

PatenSee is currently conducting a clinical trial in collaboration with Henry Ford Health to validate the performance of its system.

The company also recently announced a $2 million seed round led by Michigan Rise, with participation from Spark Capital, the Biosciences Research and Commercialization Centre (BRCC) at Western Michigan University, Kalamazoo Forward Ventures (KzFV), and Edge Medical Ventures.