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Amplifai Health has officially secured medical device marketing authorization from the Saudi Food and Drug Authority (SFDA) for Thermal Foot Scan (TFscan). This is the world’s first software as a medical device (SaMD) for diabetic foot screening.
TFscan utilizes thermal imaging and artificial intelligence to analyze heat patterns in the feet. It provides clinicians with a detailed report highlighting areas at risk for diabetic foot ulcers (DFUs) and offers recommendations and actionable steps to support early intervention. This approval marks a significant step in addressing the complications of diabetes, particularly lower-limb amputations.
Alongside this regulatory milestone, Amplifai Health has closed a funding round, securing investment from Wa’ed, Plug and Play, and Kaust innovation ventures, joining previous investors Techstars and Lamarka. This funding will accelerate the company’s mission to advance AI-powered healthcare solutions, expand its reach, and enhance the impact of TFscan in early diabetic foot screening.
Diabetes is the leading cause of lower-limb amputations worldwide, with a limb lost every 20 seconds, mainly due to diabetic foot ulcers (DFUs) [1]. Amplifai Health has built the tools to detect these ulcers early and before they progress to amputations. Unlike traditional diagnostic methods that rely on subjective visual assessment or patient symptoms, TFscan provides an objective, real-time, non-invasive AI-powered analysis of thermal patterns, allowing clinicians to detect anomalies at an earlier stage. According to the International Diabetes Federation, over 800 million people are living with diabetes around the world and the number is projected to surpass 1 billion by 2030 [2]. Diabetes continues to pose severe challenges to healthcare systems worldwide. In Saudi Arabia, at least 18.7% of adults are diabetic, clearly demonstrating the importance of proactive healthcare solutions [2]. Studies show that nearly 50% of patients who undergo a major diabetes-related amputation do not survive beyond five years [3]. “This innovation represents a bold step toward transforming diabetic care worldwide. Built in Saudi Arabia and designed to make a global impact, our AI powered solution has the potential to aid clinicians in early risk detection, support amputation prevention, and enhance patient outcomes. We are just getting started, and we’re excited to see how this technology will change lives across the world.” said Dr. Meshari Alwashmi, Amplifai Health’s CEO.
Amplifai Health’s TFscan has the potential to significantly reduce diabetes-related complications, including the 1.8 million amputations that are reported annually around the world [4]. DFUs account for approximately one-third of global diabetes-related healthcare expenditures, amounting to billions of dollars [3]. By enabling earlier detection and reducing the need for drastic interventions, TFscan substantially improves patients' quality of life by minimizing pain, disability, and long-term complications as well as dramatically lowers costs.
Clinicians and healthcare providers interested in integrating Amplifai Health’s SaMD into their practice. Please email us at contact@amplifaihealth.com or visit our website www.amplifaihealth.com
The Saudi Food and Drug Authority (SFDA) has issued its first license for a medical software and applications factory to Amplifai Health, marking a significant step forward in healthcare innovation in Saudi Arabia. This initiative is part of the results of the Licensing Initiative for Medical Software Developers in Digital Health, which was launched during the Global Health Exhibition 2024 in Riyadh. More details can be found here: https://sfda.gov.sa/en/news/2411030
About Amplifai Health
Amplifai Health is pioneering the use of artificial intelligence and imaging technology to improve early disease detection starting with diabetic foot ulcers. The company’s innovative solutions are designed to make proactive healthcare accessible, impactful, and efficient.
For further information or media inquiry, please contact: contact@amplifaihealth.com
References
1- Edmonds, M., Manu, C., & Vas, P. (2021). The current burden of diabetic foot disease. Journal of clinical orthopaedics and trauma, 17, 88-93.
2- International Diabetes Federation. (2024). Diabetes Atlas.
3- Armstrong, David G., et al. "Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer." Journal of foot and ankle research 13 (2020): 1-4.
4- Zhang, Yuqi, et al. "Global disability burdens of diabetes-related lower-extremity complications in 1990 and 2016." Diabetes Care 43.5 (2020): 964-974.
