The US Food and Drug Administration (FDA) have issued a warning regarding unapproved Diabetes technology. On February 21st 2024 the FDA released a warning about the dangers of using blood glucose monitors that are not FDA authorised. The warning is aimed at Diabetes patients and their caregivers and healthcare providers. They strongly caution against using technology that claims to be a non-invasive way of measuring blood glucose levels.
FDA warning for Diabetes patients
The devices in question are smartwatches and smart rings that do not pierce the skin to measure glucose levels. Instead, they claim to measure levels non-invasively. The FDA is warning consumers “The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.”
Any device claiming to non-invasively read blood glucose levels is different from the current smartwatch applications that display data from FDA-authorised, invasive devices. Using a non-authorised device to measure blood glucose levels comes with a very real risk of life-threatening medical issues. This is due to the inaccuracy of such readings and subsequent mismanagement of Diabetes.
Professor Dr. David Klonoff MD, a Clinical Advisor for Afon Technology, warns patients that the risk is often very large when using products that are not cleared by the FDA. In an article following the safety warning, he reminded people with Diabetes that the technology is not accurate enough.
What is the advice from the FDA regarding non-invasive smart devices?
The message from the FDA is aimed at people with Diabetes and healthcare providers. The FDA warn them not to buy smartwatches or smart rings that claim to measure blood glucose levels.
Afon Technology is a team of medical and science professionals. We are working tirelessly to create the technology for non-invasive blood glucose monitoring. When our Glucowear™ device is ready for market, Afon Technology will have the necessary regulatory approvals and marks of certification in place. You can follow our progress by signing up to our newsletter here.
