Investigational device. Limited by federal law to investigational use. This system is a working prototype and is not cleared by the FDA or any other regulatory authority for commercial sale or clinical use outside of authorized clinical investigations.
Predict the future
Labor shortage is putting significant strain on the industry
$1.2B+
5 million
1 in 5
Failed sticks / year
Annual US cost
Donors quit
30%
Phlebotomist attrition
AI / ML Detection
Speed of Assessment
Instinctive Workflow
Faster than manual palpation – vein identified before needle is uncapped
Machine learning maps vein location, diameter, and depth automatically
Designed for any phlebotomist or technician skill level
Our Solution
AI-Enabled Robotic Healthcare Automation
Who we are: ROPHAI is a medtech spin-off developing a robotic, AI-enabled phlebotomy device.
Massive underserved market: Venipuncture (blood draw) is the most common clinical procedure in the world — over 1 billion procedures globally and more than 400 million in the US alone every year. Phlebotomy roles see ~30% turnover. US Bureau of Labor Statistics projects ~10% demand growth through 2031 — a structural shortage hitting high-volume plasma and blood donation centers hardest.
Our solution: Our device automates venipuncture with consistent, repeatable performance, starting in plasma & blood donation centers, expanding to diagnostic labs, hospitals, and pharmacies.
De-risked technology: Over many years and millions+ invested in R&D, with a working prototype validated on hundreds of donors/patients.
IP protected: Licensed patent portfolio (granted and pending).
Clear path to market: Raising Series A funding to complete FDA clearance, with follow-on funding to launch commercialization.
Current stage & milestone roadmap: We have successfully developed a fully functional engineering prototype of our device. Having achieved robust benchtop and preclinical performance milestones ROPHAI is currently executing its regulatory preparation phase. Our primary objective is securing funding through a SAFE seed round at an attractive valuation to enable a 510K regulatory submission soon. We are completing our final product design based on the data gathered from our 15+ studies over many years along with human factors and actual human clinical trials done already. This is intended to support our formal submission for FDA clearance. We have active FDA engagement, 510K pathway, and alignment on a feasibility trial protocol. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device
