Clinical Safety and Intended Use

PodiaScan is intended to record contralateral (left versus right) plantar skin temperatures at six anatomical zones per foot, to store those readings against a patient record, and to display the arithmetic difference between paired zones over time.

The intended users are qualified healthcare professionals, and adults monitoring their own feet at home under the direction of a healthcare professional. The intended environment is a podiatry or diabetes clinic, or the user's home.

PodiaScan is not intended to diagnose, screen for, predict, prevent, monitor the progression of, or treat any disease or injury. It does not produce a clinical finding and it does not recommend a course of treatment.

PodiaScan is not CE-marked as a medical device and has not been assessed under Regulation (EU) 2017/745 on medical devices (MDR) or by any notified body. It must not be used, described or relied upon as a medical device.

Any number, colour, sort order or alert shown in PodiaScan is a presentation of the data the user entered, together with a threshold reported in published literature. It is not an output of a clinical algorithm and carries no clinical claim. All clinical decisions — including whether a temperature difference is significant for a given patient — remain entirely with the responsible qualified healthcare professional.

Clinics remain responsible for their own regulatory, professional-indemnity and clinical governance obligations in the jurisdiction in which they practise.

PodiaScan highlights paired zones whose difference reaches 2.2 °C. This figure is reproduced from published research and guidance; it is not a PodiaScan diagnostic rule and PodiaScan makes no claim about its accuracy or applicability to any individual patient.

“Patients were instructed to contact the study nurse if temperatures between corresponding sites on the left and right foot exceeded 4 °F (2.2 °C).”Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care 2007;30(1):14–20.

“Skin temperature differences of more than 2.2 °C between corresponding sites on contralateral feet were used as the trigger for reducing activity.”Armstrong DG, Holtz-Neiderer K, Wendel C, et al. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. American Journal of Medicine 2007;120(12):1042–1046.

The International Working Group on the Diabetic Foot (IWGDF) publishes the current consensus guidance on prevention of foot ulcers in persons with diabetes, including home-monitoring of foot temperatures. Read it at iwgdfguidelines.org.

• Accuracy depends entirely on the thermometer used. Consumer infrared and Bluetooth thermometers vary in tolerance, calibration and measurement distance.
• Ambient room temperature, recent walking, footwear, socks, bathing and dressings all change plantar skin temperature and can create or mask a difference.
• Readings are only comparable when both feet are measured at the same time, in the same conditions, at the same anatomical points.
• Findings may be meaningless in unilateral amputation, previous surgery, marked peripheral arterial disease, active infection elsewhere, or where only one foot is present or measurable.
• A difference below 2.2 °C does not mean a foot is healthy. Ulceration, ischaemia and infection can be present with no measurable asymmetry.
• Manual entry is subject to typing errors. Values are range-checked, but a plausible wrong number will be stored as entered.
• PodiaScan does not monitor patients continuously and issues no emergency alerts.

Anyone with a new wound, blister, ulcer, spreading redness, swelling, discharge, foul smell, fever, or a foot that becomes hot, cold, discoloured or painful should contact their podiatrist, GP or emergency service immediately, regardless of anything PodiaScan displays.

If you believe PodiaScan displayed incorrect data, or that its wording could mislead a patient or clinician, report it to us and we will investigate and respond. Include the date, the patient reference and what you saw.

This page describes how PodiaScan is designed and positioned. It is not legal advice and it does not replace independent regulatory or legal review. Clinics deploying PodiaScan should obtain their own advice on their obligations. Errors and omissions excepted (E&OE).