无创射频血糖穿戴手表研发公司Movano 离通过FDA许可证又进了一步。

无创射频血糖研发公司Movano 近期揭露，第二阶段的临床工作已经结束。

Wrist-worn non-invasive continuous glucose monitor from Movano takes step closer to FDA clearance after type 1 diabetes pilot study completion

Movano is known for its smart-ring wearables, which we reported on at the end of 2021. However, the company has also been busy with its smartwatch-like device that is targeting diabetics looking for an alternative to painful finger-sticking that can leave scar tissue and lead to sensitivity loss. Movano has been working on this non-invasive continuous glucose monitor (CGM) for some time, with initial reports emerging in the middle of 2020 about such a blood sugar monitor in the shape of a smartwatch.

However, while there are numerous biotech and healthtech firms seemingly chasing this dream of producing an FDA-approved painless non-invasive glucose monitor for the mass market, some disappear without a trace for years. But a recent press release from Movano has reignited interest in this particular wearable and is evidence that this device still holds promise for millions of people having to cope with daily diabetes management.

The press release reveals that a second IRB-approved study has been completed, with 10 participants comparing data produced by finger-sticking and pre-existing CGMs with a prototype Movano wrist-worn wearable. Such blood glucose level measurement comparisons will allow Movano to make the fine adjustments required to eventually get the wearable approved by the FDA.

Glucose levels are taken using Movano’s radio frequency-enabled integrated circuits, meaning there is no skin puncture or blood sample required. The wearable provides continuous data and can also track other biomarkers, such as SpO2 levels, heart rate, and blood pressure. Movano’s CEO, Dr. John Mastrototaro, hopes the end product will be both “stylish and affordable”.