• The FDA has authorized the use of an emergency kit for software that predicts whether a COVID-19 patient will develop severe high blood pressure or respiratory failure.
• EUA, issued on Tuesday, covers a CLEW treatment program that analyzes data as an important indicator of evidence that a COVID-19 patient’s condition will worsen.
• In retrospect, 5.5% of patients presented as a threat of breathing from the system wanted to start over. The technology, called the CLEWICU System, is much better at detecting people who may have high blood pressure.
Drug therapy treats a large number of COVID-19 patients facing the challenge of identifying those with severe fighting complications when their equipment is stretched. Data from ongoing research of ICU patients may have indications that patients may be malnourished, but much information about medical professionals may be based on conclusions and snapshots of available evidence.
In theory, computers are better than data analytics and human data analytics. The concept supports the CLEWICU system.
This procedure identifies important signs, nursing examinations, laboratory results, a description of the medication the patient is receiving, and knowledge sources. When the procedure demonstrates behavior that indicates a patient is at risk of respiratory failure or hemodynamic impairment, it notifies their caregiver. CLEW Medical challenges high levels can cause health professionals to stop breathing or developing hemodynamic problems, or prepare for when it will occur.
Evidence of the effectiveness of the technology from a multidisciplinary review study at CLEW Medical showed in its instructions for use. The forecast value is good, indicating a probability and an accurate warning because the respiratory rate of the system is 5.5%. This procedure usually tells doctors about a good 3.4 hours before the event.
When used to predict hemodynamic instability, the CLEWICU system had a positive efficacy of 19%. The average lead time for a good display is in the respiratory tract, closing at 3.5 hours.
The results are from a randomized controlled trial. The system is being tested at UMass Memorial Medical Center in Massachusetts and WakeMed in North Carolina and is being installed on-site in Israel, where CLEW Medical is located. The company has filed for 510 (k) abolition by the FDA but, so far, could sell its system under EUA.
EUA is part of a series of OKs for software systems designed to define the care of COVID-19 patients. Earlier this month, Eko Devices and Caption
Health received software from the FDA to help monitor and capture data needed for heart problems.