PatenSee, a clinical-stage medical device company, has secured Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-contact vascular access (VA) monitoring technology for patients receiving haemodialysis.
The designation is intended to speed up regulatory review and support faster introduction of innovative technologies in clinical settings.
PatenSee’s platform uses an AI-based optical system to monitor vascular access sites without physical contact. It has been developed to align with KDOQI guidelines, reduce the clinical workload of routine checks, and enable earlier detection of narrowing or blockages in blood vessels.
Vascular access is vital for patients on haemodialysis, but regular checks are often time-consuming and inconsistently performed.
Problems with vascular access remain a major cause of illness, poorer quality of life and rising healthcare costs.
By automating and standardising the monitoring process, the company’s technology is designed to improve early diagnosis of complications, allow timely intervention, and cut financial pressures for both healthcare providers and insurers.
