Your U.S. Partner for Clinical & Regulatory Success


We help Israeli medical device and digital health companies bring their innovations to the U.S. market with confidence, compliance, and speed.

Contact Us

From Israel to the U.S. We’ve Got You Covered

Bringing a medical device to the U.S. is a complex journey—but you don’t have to do it alone.
With SPMD Pathway, you gain a true extension of your team. Custom-tailored, results-driven, and on budget. 
At SPMD Pathway, we become your trusted U.S.-based partner, leading your clinical and regulatory pathway with clarity and confidence.

Learn more about what we do - 

End-to-End Project Oversight

We manage your project like it’s our own—every detail, every milestone.

The U.S. medical device market is the largest and most regulated globally, requiring your product to demonstrate clinical validity, real-world effectiveness, and regulatory compliance with entities like the FDA.

As your on-the-ground partner in the U.S., we provide end-to-end project oversight, ensuring smooth coordination and alignment throughout the clinical and regulatory process.

Contact US
We look forward to partnering with you for your product’s success!

Message Sent!

Your message has been sent successfully, I hope to respond within 24 hours. You can also contact us through social media, links can be found below!

United States 

2897 N Druid Hills Rd NE ste 101
Atlanta, GA, 30033

+1 404 578 5670

Israel

Tel - Aviv
+972 51 650 4030

[email protected]

© 2025 SPMD PATHWAY