

Wara Samar
4th February 2025
Amplifai Health’s AI Diabetic Foot Scanner Gets SFDA Green Light
Amplifai Health has received medical device marketing authorization from the Saudi Food and Drug Authority (SFDA) for its Thermal Foot Scan (TFscan), the world’s first software as a medical device (SaMD) for diabetic foot screening. This milestone underscores a major advancement in early detection and prevention of diabetic foot ulcers (DFUs), a leading cause of lower-limb amputations worldwide.
The Growing Threat of Diabetic Foot Ulcers
Diabetes remains a global health challenge, with over 800 million people currently affected, a number projected to exceed 1 billion by 2030. Among its severe complications, DFUs stand out as a major concern, contributing to 1.8 million amputations annually. In Saudi Arabia alone, 18.7% of adults are diabetic, emphasizing the urgent need for proactive healthcare solutions.
DFUs develop when prolonged high blood sugar levels damage nerves and blood vessels in the feet, leading to reduced sensation and poor circulation. This makes minor injuries more likely to go unnoticed and slow to heal, increasing the risk of infections and severe complications. If left untreated, DFUs can lead to gangrene and, ultimately, amputation. Shockingly, nearly 50% of patients who undergo major diabetes-related amputations do not survive beyond five years.
How TFscan is Changing the Game
Traditional diabetic foot screening relies on visual assessments and patient-reported symptoms, which can be subjective and prone to late-stage detection. TFscan leverages thermal imaging and artificial intelligence to analyze heat patterns in the feet, providing clinicians with an objective, real-time, and non-invasive diagnostic tool. By detecting temperature irregularities that indicate early-stage ulcers, TFscan enables earlier intervention, significantly reducing the risk of complications.
The AI-driven technology generates a detailed report highlighting at-risk areas and offers actionable recommendations for healthcare providers. This empowers clinicians to take preventive measures, reducing the likelihood of ulcer progression and, ultimately, amputations.
A Global Impact with Local Innovation
Developed in Saudi Arabia, TFscan has the potential to transform diabetic care worldwide. The economic burden of DFUs is immense, accounting for nearly one-third of global diabetes-related healthcare costs. By improving early detection, TFscan can lower healthcare expenditures while enhancing patient outcomes.
Beyond cost savings, the technology improves the quality of life for diabetes patients by minimizing pain, disability, and long-term complications. It represents a shift toward preventative, data-driven healthcare—an approach that not only benefits individuals but also eases pressure on healthcare systems.
Dr. Meshari F. Alwashmi, Chief Executive Officer of Amplifai Health, has been a frequent speaker at MedTech World events, including the Dubai Roadshow in 2024 and MedTech Malta 2023.
Read More: AmplifAI Health Reaches Top 3 in Entrepreneurship World Cup
With SFDA approval, TFscan is set to advance diabetic foot screening, offering a powerful solution to a longstanding medical challenge. As diabetes rates continue to climb, innovations like TFscan will play a crucial role in safeguarding millions of lives and preventing avoidable amputations.
Join Us on the Road to MedTech World Dubai
Before we gather for MedTech World Dubai on 23-24 February, our team will be at LEAP 2025 from 9 to 12 February. Dr. Dylan Attard, Co-Founder and CEO of MedTech World, will take the stage on 10 February for the panel “The New Health Stack: Apps, Analytics & Automation,” where he’ll discuss the evolving role of technology in healthcare. Join industry leaders to explore the latest developments in healthcare at MedTech World Dubai. Secure your spot today!
