PatenSee Receives FDA Breakthrough Device Designation for AI-Driven Hemodialysis Monitoring System
核心洞察
PatenSee (搜索) has received FDA Breakthrough Device Designation for its non-contact vascular access (搜索) management technology designed for hemodialysis patients, providing a streamlined regulatory pathway for development.
The AI-driven optical monitoring system enables touch-free physiological monitoring aligned with KDOQI guidelines and aims to support early detection of stenosis (搜索) complications.
The company is conducting clinical validation trials with Henry Ford Health (搜索) and recently secured $2 million in seed funding to advance the technology toward market deployment.
PatenSee (搜索), a clinical-stage medical device company, announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its non-contact vascular access (搜索) management technology designed for patients undergoing hemodialysis. The designation provides a streamlined regulatory process to accelerate the development and adoption of PatenSee's platform in dialysis clinics.
The 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 (搜索) monitoring, support early detection of stenosis (搜索), and establish a new standard of care in dialysis management.
"This recognition highlights PatenSee (搜索)'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.
Addressing Critical Unmet Medical Need
In hemodialysis, the vascular access (搜索) 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. Vascular access-related complications remain a leading cause of morbidity, impaired patient quality of life, and substantial healthcare costs.
PatenSee (搜索)'s breakthrough technology has the potential to help clinicians identify vascular access (搜索)-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.
Clinical Development and Funding
PatenSee (搜索) is currently conducting a clinical trial in collaboration with Henry Ford Health (搜索) to validate the performance of its system. The company also recently announced a $2 million seed round led by Michigan Rise (搜索), with participation from Spark Capital (搜索), the Biosciences Research and Commercialization Centre at Western Michigan University, Kalamazoo Forward Ventures, and Edge Medical Ventures.
The company was founded at the MEDX Xelerator venture studio supported by the Israeli innovation authority, and is based in Detroit, Michigan, and Or Yehuda, Israel. Using advanced, multi-modal imaging technologies, AI, and machine learning, PatenSee (搜索)'s system alerts caregivers of vascular access (搜索) stenosis (搜索) 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.
The PatenSee (搜索) system is not yet approved by the FDA and is limited by U.S. law to investigational use only.