The AI-driven optical system is designed for early detection of stenosis in hemodialysis patients and to reduce clinical staff workload.
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to PatenSee for its non-contact vascular access (VA) management technology for patients undergoing hemodialysis. The designation provides a streamlined regulatory process to accelerate its development and review.
PatenSee’s platform is an AI-driven optical monitoring system developed to provide touch-free physiological monitoring. According to the company, the technology is designed to lessen the clinical burden of VA monitoring and support the early detection of stenosis, a common complication for dialysis patients.
In hemodialysis, complications related to the VA site are a leading cause of morbidity and contribute to significant healthcare costs. The company notes that while routine monitoring is essential, it can be time-consuming and performed inconsistently. PatenSee’s system aims to standardize and streamline this process to help clinicians identify potential complications earlier than the current standard of care.
“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,” says Paul Neeb, CEO, in a release.
Advancing Toward Clinical Validation
PatenSee is currently conducting a clinical trial in collaboration with Henry Ford Health to validate the system’s performance. The company also recently announced it had raised a $2 million seed round to support its development efforts.
The PatenSee system is not yet approved by the FDA and is limited by US law to investigational use only.
Photo caption: VA management system
Photo credit: PatenSee
