FDA Gives Landmark Clearance to CLEW’S AI-Driven ICU Predictive Tool

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Source: https://clewmed.com/technology/?cn-reloaded=1#Data_processing

CLEW has come up with a Medical Intense Care Unit tool that uses machine learning (ML) models to identify patients’ conditions. The United States Food and Drug Administration (FDA) has permitted (510k Clearance) using the above AI medical tool. This is the first time for FDA to give clearance to such a tool. 

The tool predicts hemodynamic instability in adult patients in ICU. The tool is named CLEWICU, and it uses Artificial Intelligence algorithms and ML models to identify the likelihood of significant clinical events for ICU patients.

According to Dr. David Bates, CLEW Advisory Board member, AI can be a powerful healthcare change force. It can enable assessment of time-critical patient information and predict deterioration health that could help better clinical decisions and improve the ICU outcomes.

Hemodynamic instability is a condition when there is abnormal blood pressure, which can cause inadequate blood flow to your organs. The instability symptoms may include

  • Decreased urine output
  • Low blood pressure (hypotension)
  • Loss of consciousness
  • Abnormal heart rate and Chest pain
  • Cold hands, arms, legs, or feet, or bluish discoloration of these areas
  • Confusion, Restlessness, and Breath shortness 

Hemodynamic instability is a common COVID-19 complication. CLEWICU’s predictive ability could prove useful during the ongoing Covid pandemic. CLEWICU provides a picture of the overall unit status by analyzing patient data from various sources and identifying individuals with deteriorating health conditions. The system notifies users of deterioration condition in advance by eight years. The above enables early intervention.    

The emergency use authorization was provided by FDA to CLEWICU back this past June. The tool was one of the several AI-powered innovations in technology that was built, or modified, in response to the ongoing pandemic.   

According to Cris Ross, Mayo Clinic Chief Information Officer, Artificial Intelligence has been crucial in understanding the Covid pandemic.

The model is already proven successful in the ICU and is now being extended to all care settings. The model is designed in a way to guide the healthcare workers predict the patient’s health state. CLEW helps make informed clinical decisions, improves outcomes, and better deals with increased regulation. The tool also lowers the cost of care.

Source: https://clewmed.com/clew-medical-receives-fda-clearance-for-ai-based-predictive-analytics-technology-to-support-adult-icu-patient-assessment/

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