PatenSee’s monitoring system for the vascular access stenosis detection in haemodialysis patients. Credit: PRNewswire/PatenSee.

Fistula monitoring system developer for dialysis patients PatenSee has signed a clinical collaboration agreement with Fresenius Medical Care.

The companies will conduct a joint, multi-centre pilot trial of PatenSee’s contactless monitoring system within Fresenius Medical Care’s dialysis clinics in Israel.

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This system is intended for early vascular access stenosis detection in haemodialysis patients.

It uses artificial intelligence (AI) and machine learning, multi-modal imaging technologies to alert caregivers of an access stenosis risk in the initial stage.

The pilot trial is scheduled to begin in the first quarter of 2024.

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PatenSee chairman Shai Policker said: “PatenSee’s goal is to enhance the quality of patient monitoring and reduce complications while alleviating the burden on clinical staff.

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“We are happy to start this new phase of implementing PatenSee’s contactless monitoring technology and even happier to perform this study in collaboration with Fresenius Medical Care with its wealth of experience and clinical expertise.”

PatenSee’s strategic plan includes expanding the trial to additional clinics in the US.

The objective is to gather sufficient data to pursue the US Food and Drug Administration (FDA) clearance for the contactless monitoring system.

Fresenius Medical Care Israel venture innovation manager Adi Shaked said: “Timely monitoring and analysis of the fistula status of haemodialysis patients are major clinical unmet needs and PatenSee’s contactless, rapid monitoring has the potential to make a significant impact in dialysis patients.”

Last year, Fresenius secured 510(k) clearance from the FDA for VersiHD with GuideMe Software designed to enhance patient training time and ease the transition to home for patients.

The new self-guided interface is used for the company’s VersiHD chronic home hemodialysis system.

The software offers graphical walk-through guidance, which seeks to improve user-friendliness for both nurses and patients.