BACC Member, a Startup from Lithuania Feetsee Announces its Registration with the FDA

Feetsee is now an FDA-registered Class I medical device designed for people living with diabetes and neuropathy. The Feetsee device measures the temperature of the feet for signs of inflammation. Temperature monitoring is a proven way to help reduce the number of diabetic foot ulcers in multiple clinical studies over the past 20 years. It is widely considered as the best method for the early detection of ulcers. The Feetsee device is designed for patients with diabetes for use at home, and healthcare professionals monitor the information from the device. The doctor or nurse reviews the Feetsee monitoring results and determines if a clinic visit is necessary.

Feetsee’s FDA registration crowns two years of rigorous development and testing. The Feetsee device was validated based on the data collected from 112 patients with diabetes and healthy volunteers (NTC05222490). Furthermore, the Feetsee clinical trial demonstrated Feetsee’s similar performance to medical-grade thermal camera Med-Hot’s FLIR A400 / FLIR A700-Series Thermal Smart Sensor combined with FDA-approved TotalVision medical application software.

Diabetis, JSC  team had previously published the Feetsee algorithm testing results in a peer-reviewed Electronics publication titled “Algorithm for Automated Foot Detection in Thermal and Optical Images for Temperature Asymmetry Analysis” (https://www.mdpi.com/2079-9292/10/5/571).

The company has already established a US presence with Feetsee Inc. and launched a Series A financing round with two US-based investment entities as co-leads. 

Learn more about Feetsee here

For more information about Feetsee please feel free to contact us at info@bacc.nyc