Breaking Update
Israeli-American Startup PatenSee Gains FDA Approval Boost for Hemodialysis Technology
Israeli-American startup PatenSee secures FDA approval for breakthrough hemodialysis technology, aiming to improve patient outcomes.
Jerusalem, 17 September, 2025 (TPS-IL) — PatenSee, a clinical-stage medical device company with dual bases in Detroit and Or Yehuda, Israel, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its non-contact vascular access management system for hemodialysis patients. The AI-driven platform is designed to detect complications earlier, reduce clinical workload, and improve patient outcomes.
The company, founded at Israel’s MEDX Xelerator venture studio with support from the Israeli Innovation Authority, is conducting clinical trials with Detroit’s Henry Ford Health and backed by Michigan-based investors. The designation accelerates regulatory review, highlighting the Israeli-American startup’s role in advancing next-generation dialysis care.
