Empo Health Selects Interlynk to Enhance Cybersecurity & FDA Compliance for Remote Diabetic Foot Ulcer Monitoring

Partnership accelerates FDA-aligned cybersecurity compliance for Empo Health’s remote diabetic care platform through automated SBOM and vulnerability management

MENLO PARK, CA, UNITED STATES, July 29, 2025 /EINPresswire.com/ -- Interlynk, a leading provider of SBOM automation and cybersecurity compliance solutions for connected medical devices, today announced a strategic partnership with Empo Health, the company behind a groundbreaking system for remote diabetic foot ulcer (DFU) monitoring. Interlynk will support Empo’s software supply chain assurance and FDA and other regulatory cybersecurity compliance.

Empo Health’s FDA-listed Empo^® Footprint imaging scale and HIPAA-compliant Empo^® Remote Health Link platform enable early detection of diabetic foot ulcers by healthcare providers through near-daily, at-home monitoring. The system addresses a critical unmet need - more than 20 million Americans with diabetic neuropathy are at high risk of foot ulcers, which lead to over $80 billion in annual healthcare costs. In recent pilot studies, nearly half of the users showed early ulcer signs detected through the use of Empo’s platform.

With increased FDA scrutiny under its Refuse to Accept (RTA) policy, as well as a cybersecurity focus from the EU’s Medical Device Regulation (MDR) and the upcoming Cyber Resilience Act (CRA), medical device manufacturers must demonstrate robust software transparency, vulnerability management, and secure development practices. Interlynk’s platform is purpose-built to address these challenges.

“Empo Health is delivering life-changing innovation with a modern approach to chronic disease management,” said Surendra Pathak, CEO at Interlynk. “We’re proud to support their engineering and regulatory teams by automating SBOM generation, vulnerability tracking, and FDA-aligned compliance workflows.”

Through the partnership, Interlynk enables Empo Health to:
- Generate and manage machine-readable SBOMs in both CycloneDX and SPDX formats
- Monitor open-source and third-party software for vulnerabilities in real time
- Maintain audit-ready documentation for premarket submissions and postmarket surveillance
- Align with FDA premarket cybersecurity guidance, postmarket requirements, and EO 14028

“Cybersecurity is critical to the trust our patients and doctors place in our products,” said Eric Dahlseng, Co-Founder and Chief Product Officer of Empo Health. “With Interlynk, we gain full visibility into our software supply chain while staying continuously prepared for regulatory reviews in a constantly evolving cybersecurity landscape.”

The partnership exemplifies a growing shift in the medical device industry toward proactive and automated approaches to cybersecurity compliance. By integrating directly into Empo’s development lifecycle, Interlynk helps ensure secure-by-design development, critical for devices with real-world impact on patient safety and outcomes.

About Empo Health
Empo Health^®, founded in 2020 by MIT- and Stanford-trained engineers and based in the San Francisco Bay Area, delivers an FDA-listed digital health system consisting of the Empo Footprint imaging scale and Empo Remote Health Link platform. It enables near-daily imaging and clinician review to detect early signs of diabetic foot ulcers—helping patients and their doctors prevent disability, hospitalization, and amputation. See the recent press release 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, and other global regulatory standards.

Media Contacts
Empo Health
press@empohealth.com

Neel Mishra
Interlynk
hello@interlynk.io

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