Secure, Safe and Smarter: PolarFire® FPGAs in Next-Generation Medical Imaging

The medical imaging industry is evolving at a remarkable pace. From handheld ultrasound scanners that bring diagnostics directly to the bedside to AI-driven CT and MRI systems that deliver faster, sharper and more accurate results, technology is transforming patient care. But this progress brings new challenges—chief among them being providing data security and functional safety.

The Dual Challenge: Security and Safety in Medical Imaging

Modern healthcare is interconnected, with devices sharing data across vast digital ecosystems. Medical images contain not just pixels but also sensitive patient information, making them a prime target for cyberattacks such as ransomware, data manipulation and unauthorized access. Regulations like HIPAA (U.S.) and GDPR (Europe) mandate strict safeguards—but compliance is more than a legal necessity. It’s a matter of patient safety and trust.

Beyond cybersecurity lies another critical concern: functional safety. Here, the question isn’t about malicious threats but about preventing hazards that could arise from a system’s correct or incorrect operation. International standards set the bar:

• IEC 61508 defines risk-based processes for safety in electronic systems and introduces Safety Integrity Levels (SILs) to quantify risk reduction.
• IEC 60601 provides detailed requirements for the basic safety and essential performance of medical electrical equipment, covering electrical, mechanical and electromagnetic aspects to protect patients and clinicians.

Meeting both standards is essential for any medical imaging solution aiming to deliver safe, reliable and compliant performance.

Why PolarFire^® FPGAs Are Uniquely Positioned

Field Programmable Gate Arrays (FPGAs) stand out in addressing these challenges. Unlike fixed-function processors, FPGAs can be reconfigured at the hardware level for parallel, low-latency and power-efficient computation—fit for imaging and AI workloads. Our PolarFire FPGAs take these benefits further, offering features specifically designed for security, safety and compliance.

Key Advantages for Medical Imaging

• Certified for Functional Safety

PolarFire FPGAs are certified by TÜV Rheinland^® up to IEC 61508 SIL 3, giving developers a pre-certified platform for safety-critical designs. This dramatically reduces development effort, cost and certification timelines compared to starting from scratch.

• Built-in Security for Patient Data

With a dedicated User Cryptoprocessor and anti-tamper protection, PolarFire FPGAs provide hardware-level safeguards against cyber threats. These include resistance to side-channel attacks like Differential Power Analysis (DPA) and active tamper detection for enhanced system integrity.

• Nonvolatile, Low-Power Architecture

Unlike SRAM-based devices, Flash-based PolarFire FPGAs offer instant, secure boot-up in a known-safe state. Their low power consumption is a suitable fit for portable and miniaturized imaging devices, where long battery life and reliability are critical.

• Real-Time AI and Imaging Performance

Medical imaging requires real-time processing for noise reduction, enhancement and AI analysis. PolarFire FPGAs handle high-resolution data streams with minimal latency, enabling clinicians to get fast, reliable diagnostic insights.

• Meeting the IEC 60601 Challenge with PolarFire FPGAs

For medical device manufacturers, compliance with IEC 60601 is non-negotiable. By pairing functional safety certification (IEC 61508) with built-in security, PolarFire FPGAs provide a solid foundation for developing imaging solutions that meet IEC 60601 requirements.

The result? A faster path to building safe, secure and standards-compliant medical devices—from portable ultrasound to advanced MRI—while reducing development risks and costs.

Conclusion: A Trusted Platform for the Future of Imaging

The future of medical imaging demands devices that are secure against cyber threats, safe against functional failures and compliant with international standards. With PolarFire FPGAs, developers gain exactly that: a pre-certified, robust and low-power platform that simplifies the journey to compliance while enabling cutting-edge innovation in imaging.

By choosing PolarFire FPGAs, medical device manufacturers can accelerate time-to-market, protect patients and data and confidently meet the challenges of IEC 60601 and IEC 61508 compliance—all while delivering smarter, safer and more reliable imaging solutions.