Empo Health Selects Interlynk to Enhance Cybersecurity & FDA Compliance for Remote Diabetic Foot Ulcer Monitoring
- interlynk
Empo Health’s Innovation in Chronic Care
Empo Health’s FDA-listed solutions include:
Empo® Footprint imaging scale
Empo® Remote Health Link platform (HIPAA-compliant)
These tools enable early detection of diabetic foot ulcers by healthcare providers through near-daily, at-home monitoring.
The need:
Over 20 million Americans with diabetic neuropathy are at high risk of ulcers.
DFUs cost the U.S. healthcare system $80 billion annually.
In pilot studies, nearly half of users showed early ulcer signs detected by Empo’s platform.
Growing Regulatory Pressures
Medical device manufacturers face heightened cybersecurity scrutiny, including:
FDA’s Refuse to Accept (RTA) policy
EU Medical Device Regulation (MDR)
Upcoming Cyber Resilience Act (CRA)
These frameworks demand software transparency, vulnerability management, and secure development practices—areas directly addressed by Interlynk’s platform.
Partnership Impact
“Empo Health is delivering life-changing innovation with a modern approach to chronic disease management. We’re proud to support their engineering and regulatory teams by automating SBOM generation, vulnerability tracking, and FDA-aligned compliance workflows,”
— Surendra Pathak, CEO, Interlynk
Through this partnership, Interlynk enables Empo Health to:
Generate and manage machine-readable SBOMs (CycloneDX & SPDX formats).
Monitor open-source and third-party software for vulnerabilities in real time.
Maintain audit-ready documentation for premarket and postmarket compliance.
Align with FDA cybersecurity guidance, postmarket requirements, and Executive Order 14028.
Ensuring Patient Trust
“Cybersecurity is critical to the trust our patients and doctors place in our products. With Interlynk, we gain full visibility into our software supply chain while staying continuously prepared for regulatory reviews in a constantly evolving cybersecurity landscape,”
— Eric Dahlseng, Co-Founder & CPO, Empo Health
Industry Significance
The partnership highlights a growing shift in the medical device industry toward proactive and automated cybersecurity compliance.
By integrating directly into Empo’s development lifecycle, Interlynk helps ensure secure-by-design development — critical for devices that directly impact patient safety and outcomes.
About Empo Health
Founded in 2020 by MIT- and Stanford-trained engineers, Empo Health® is based in the San Francisco Bay Area. Its FDA-listed digital health system includes the Empo Footprint imaging scale and Empo Remote Health Link platform, enabling near-daily imaging and clinician review to detect early signs of diabetic foot ulcers.
Learn more at: https://empo.health/news
About Interlynk
Interlynk offers a SaaS cybersecurity and SBOM automation platform designed for medical device innovators. Its real-time visibility and continuous compliance workflows support adherence to:
FDA cybersecurity guidance
Executive Order 14028
Other global regulatory standards
Learn more at: interlynk.io