Tight Alright Blinded

This app connects with FeelTect’s wearable pressure sensing device for monitoring compression therapy – Tight Alright. The app enables users to view the pressure being applied by compression products, for example, in the treatment of venous leg ulcers (VLUs). Data can be optionally shared with FeelTect’s cloud platform for remote monitoring purposes. In this version, the pressure values have been blinded to the point-of-care user. The most common use case for this is in clinical studies where it is sometimes necessary to blind participants Tight Alright Blinded has already been registered with EudaMed for use in Europe and with the FDA for use in USA. In both juristictions, the technology is classified as class I, the lowest-risk medical device technology. As an ISO13485 certified company, FeelTect has implemented comprehensive processes and procedures in areas of (i) risk management, (ii) design and development (iii) documentation and record keeping (iv) product realization and (v) market surveillence all prioritizing patient safety.studies where it is sometimes necessary to blind participants