Friday, May 9, 2025
5/9/2025
Wireless Wearable with AI Analytics for Monitoring Neonatal Abstinence Syndrome (NAS) - PROJECT SUMMARY Neonatal abstinence syndrome (NAS) is an opioid withdrawal syndrome that develops shortly after birth to in utero-exposed neonates. Newborns with NAS typically receive care in the Neonatal Intensive Care Unit (NICU), where the daily cost of care is high, costing $2.5 billion per the 22,000 infants born with NAS and an average cost of $79 937.75 per baby annually [47]. Although there are medication-based interventions for the treatment of NAS, which are used in up to 80% of opioid-exposed infants, these treatments carry their own risks of toxicity and drug interactions [48]. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the NICU, for these babies [4]. There is an urgent need for innovative new methods to reliably diagnose NAS and thoroughly assess the efficacy of responses to treatment. Rekovar has worked diligently to develop Neomonki (Neonatal Monitoring Kit), a simple economical solution to objectively assess and treat NAS. Neomonki is an affordable, wearable monitoring device that continuously reports measures of behavioral and physiological symptoms correlating to NAS that may otherwise go unnoticed to healthcare professionals. Neomonki consists of wireless wearable wristbands fitted with biosensor technology, a tablet fitted with Rekovar’s healthcare portal enhanced with robust encryption/data collection capabilities, a charging dock station which powers the tablet and allows easy access to recharge the wristbands, a camera attached to the dock station to analyze imaging properties, and a portable cart which holds the dock station and allows for easy repositioning of Neomonki. Neomonki will revolutionize neonatal healthcare with a cutting-edge AI (Artificial Intelligence) clinical algorithm that analyzes biosensor and imaging data to deliver predictive NAS analytics and enhance diagnostic decision-making. Rekovar has successfully pursued several objectives to enhance the performance of Neomonki, including size reduction and improved functionality and safety features. Rekovar has also made strides in improving Neomonki’s software graphical user interface, ensuring that it is user-friendly and functional. However, the device's success depends on the development of the AI algorithm for assessing patient symptoms and prescribing appropriate treatments. This proposal revolves around the collection of data in clinical trials to develop, optimize, and refine an algorithm for assessing NAS symptoms in neonatal patients with the Neomonki. This will be done in two phases: i) the initial data collection and publication on the advantages of continuous monitoring in NAS neonates using Neomonki, the development of an AI algorithm to automate symptom scoring with high accuracy, and the preparation for an FDA De Novo submission for the Neomonki wearable. And ii) validating the AI algorithm through a second clinical trial, conducting a pilot study to establish the Neomonki device's effectiveness in improving clinical outcomes, expanding the AI algorithm to include FNASS scoring with high accuracy, and achieving FDA De Novo approval for the Neomonki system. These clinical trials will compare the performance of Neomonki against the currents standards of care used by participating hospitals. A key milestone of this stage of the project is to assess whether the optimized automated digital scoring and suggested treatment algorithm can improve clinical outcomes, shorten hospital stays, and decrease daily costs. Achieving this milestone will allow Neomonki to be used commercially to automate digital assessments and treat patients.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).