Detalo Clinical™ – Medical Device CO Rebreather
Medical Device for Blood Volume Measurement
Blood Volume is an critical parameter the treatment of several critical diseases such as heart failure, kidney diseases and other illnesses that affect the circulatory system. Clinical evidence suggest that significant improvements exist if blood volume guided treatments are used by medical doctors. The Detalo Clinical™ is being developed as a medical device to be used in normal clinical flow and the use of CO rebreathing makes it available and affordable for use in most medical facilities.
Detalo Clinical™ is under development and is aimed for European and US market approval during 2021.
Detalo Clinical™ will be certified as a medical device but is not intended to diagnose or treat illnesses. Blood volume measurements are meant to help the treating medical doctor make a better evaluation of patients and support their decision making.
Detalo Blood Volume Analyzers
Detalo automatically determines total blood volume, red blood cell volume and plasma volume in humans in a rapid, safe and precise manner.
The Detalo Performance is to be used for athletes and science and is available for purchase today. The Detalo Clinical is currently going through the medical certification procedures and should be available for clinical use in 2020.
Will be certified as a Medical CE Certified Device
The Detalo will be thoroughly analysed according to both EU as well as US regulatory guidelines.
The CE mark shows that the device meets the legal requirements for medical devices. To place a CE mark on a medical device, the manufacturer must document the product’s quality, safety and performance.