Industrialization and clinical testing of NeoDoppler – a novel system for neurological monitoring of high-risk infants

NeoDoppler is a novel, non-invasive method to monitor cerebral blood flow continuously. By recording and analyzing the cerebral circulation in different depths of the brain simultaneously, the timing of medical interventions can be optimized. The NeoDoppler probe is operator independent and can be gently fixed to the fontanel by a specially designed housing. NeoDoppler is a unique and patented concept, not currently available anywhere worldwide, with the potential to reduce the risk of brain damage when commercialized and offered to the health care service. Currently, there are two main clinical settings where NeoDoppler may be used to provide critical information for improved patient treatment and outcome: • The first is monitoring in the newborn intensive care unit (NICU) and the pediatric intensive care unit (PICU), where continuous monitoring is essential to detect changes in cerebral blood-flow allowing the doctor in charge to make timely decisions to normalize cerebral blood flow. • The other is during surgery or interventions, where NeoDoppler may provide the surgical team with valuable information about how the intervention affects cerebral blood-flow, allowing for adjustments in the procedure to secure optimal cerebral blood supply. NeoDoppler has the potential to become a new Standard of Care (SoC), as a bedside and surgical intervention monitoring system for high-risk infants, leading to better overall patient care and increase the survival of infants without disabilities. The product will include a stand-alone display unit to connect to the ultrasound scanner unit. The device will be easy-to-use, and the sensor can be attached via a disposable ultrasound transducer to the fontanelle of the child by any pediatric nurse with a proprietary disposable fixation accessory. The display unit will provide key parameters on cerebral circulation. The monitor system will give alarms whenever they indicate an adverse clinical state.