PatenSee Receives FDA Breakthrough Device Designation for Non-Contact Vascular Access Management for Patients Undergoing Hemodialysis

Designation supports accelerated development of AI-driven platform to improve outcomes and reduce clinical burden.

DETROIT and OR YEHUDA, Israel, Sept. 16, 2025 /PRNewswire/ -- PatenSee, a clinical-stage medical device company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its 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. 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.

"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.

Address a Critical Unmet Need in Dialysis Care

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.

Advancing Toward Clinical Validation

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.

About PatenSee
PatenSee is a clinical-stage medical device company developing a non-contact monitoring system for the early detection of vascular access stenosis in hemodialysis patients. Using advanced, multi-modal imaging technologies, AI, and machine learning, PatenSee's system alerts caregivers of vascular access stenosis risk at the earliest stage, enabling timely interventions to protect the patient's hemodialysis lifeline, improve the quality of care, and prolong the life of the fistula.

PatenSee was founded at the MEDX Xelerator venture studio supported by the Israeli innovation authority, and is based in Detroit, Michigan, and Or Yehuda, Israel.

The PatenSee system is not yet approved by the FDA and is limited by U.S. law to investigational use only.

For more information visit https://patensee.com.

Media Contact:

Paul Neeb
CEO
info@patensee.com
(720) 256-0187

Photo - https://mma.prnewswire.com/media/2774312/PatenSee_Photo.jpg

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SOURCE PatenSee