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CLEWICU

by Clew Medical · Based in Israel → — Intelligent Clinical Surveillance: Predicting the Risk of Patient Deterioration

Cardiology Critical Care Hospital Medicine

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Not publicly disclosed

Regulatory Status Disclosed

Overview

CLEWICU by Clew Medical is an FDA-cleared, AI-driven clinical surveillance and predictive analytics platform designed for early patient deterioration detection in high-acuity care settings. The platform utilizes proprietary machine-learning models to forecast patient deterioration, such as respiratory failure and hemodynamic instability, up to eight hours before physiological signs or other monitoring systems would indicate. Initially developed for Virtual ICUs (VICUs) and Tele-ICUs, CLEWICU has expanded its capabilities to all inpatient settings, including the Emergency Department (ED), medical/surgical floors, and perioperative suites.

CLEWICU is built for large, data-rich, enterprise deployments and is EHR-agnostic, aggregating data from various clinical sources like EMRs, ADT systems, patient monitoring systems, and life support devices to create a real-time physiological profile for each patient. The system aims to reduce alarm fatigue, generate fewer alarms than traditional monitoring systems, and provide clinicians with actionable insights for proactive intervention, improved capacity management, and better resource optimization.

The platform also supports customizable best practice clinical protocols, offers a Sepsis Virtual Unit (SVU) to enhance sepsis detection and SEP-1 compliance, and includes a Heart Failure Virtual Unit (HFVU). CLEW’s predictive insights have been documented to be highly accurate, significantly improving clinical outcomes and operational efficiency.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI-powered predictive analytics
Real-time patient deterioration prediction (up to 8 hours in advance)
Customizable best practice clinical protocols
NotifyMe smart alerting (low alarm fatigue)
Unified patient view and Unit View dashboards
Automated APACHE score documentation
Sepsis Virtual Unit (SVU)
Heart Failure Virtual Unit (HFVU)
Rounding Tool
EHR-agnostic data aggregation

Use Cases

Early patient deterioration prediction
Virtual ICU/Tele-ICU operations
Sepsis detection and SEP-1 compliance
Clinical decision support
Capacity management and throughput optimization
Reducing alarm fatigue and clinician burnout

What Physicians Need to Know

Evidence Base

CLEWICU utilizes AI-driven prediction models and proprietary machine-learning models, trained on nearly 100,000 ICU patients. It incorporates customizable best practice clinical protocols and is designed for interpretability, validated across multiple hospital datasets. The system is FDA-cleared as a Class II medical device, with clearances for predicting hemodynamic instability (February 2021) and an Emergency Use Authorization for respiratory deterioration (June 2020). Second-generation AI/ML models received 510(k) clearance in May 2024.

Clinical Validation Studies

Peer-reviewed studies, including one published in CHEST Journal (April 2024), demonstrate CLEW's AI-driven models are five times more accurate than alerts from leading telemedicine systems, based on data from two major US health systems. FDA clearance was supported by retrospective clinical and human factors validation. Models were trained using supervised learning on patient data from 7 ICUs at two University of Massachusetts hospitals and externally validated on data from 7 ICUs at two WakeMed Health System hospitals. Software validation adheres to IEC 62304:2015-06.

Alert Fatigue Management

CLEWICU significantly reduces alert fatigue by generating up to 50 times fewer alarms than other leading patient monitoring systems, thereby decreasing cognitive burden and nursing burnout. Its accurate, multi-variable models produce substantially fewer false alerts compared to threshold-based systems. The 'NotifyMe' smart alerting tool allows for custom, multi-parameter notifications configurable at the system, unit, or individual patient level.

Override Rate Data

Specific override rate data is not explicitly provided. However, CLEWICU is intended as a decision support tool, and its predictions are for reference only, not to be the sole basis for therapeutic decisions, implying that clinical judgment and potential overrides are an expected part of its use.

Guideline Update Frequency

The platform includes built-in best practice clinical protocols that are easily customizable by hospitals. A Predetermined Change Control Plan (PCCP) allows CLEWICU models to be retrained with new datasets to improve sensitivity and performance, following strict internal and FDA-reviewed protocols for training, testing, and validation.

Clinical Workflow Integration

CLEWICU is EHR-agnostic, integrating seamlessly with existing EMRs, ADT systems, patient monitors, and life support devices to aggregate real-time patient data. Features like 'One Click' enable quick access to EMR data for order entry or documentation without re-logging. It offers a real-time, priority-driven patient worklist ('Rounding Tool') and unified patient/unit views to streamline care and resource allocation. The system aims to enhance existing workflows without requiring fundamental changes.

Decision Audit Trail

The platform facilitates the extraction of historical patient data into business intelligence tools for reporting and research, suggesting that data related to alerts and system insights are available for audit and analysis.

Physician Tip

Leverage CLEWICU's predictive insights for proactive care, focusing on the early identification of respiratory failure and hemodynamic instability up to eight hours in advance. Utilize the significantly reduced alarm burden to minimize cognitive overload and enhance focus on critical patients. Customize alert parameters via 'NotifyMe' to align with specific patient needs or unit protocols. Integrate the patient worklist and unified views into daily rounds to prioritize care based on real-time acuity and risk profiles. Remember that the system provides decision support and physiological insight; always combine its predictions with your clinical judgment and comprehensive patient data.

CLEWICU is designed for broad interoperability, functioning as an EHR-agnostic platform that collects and aggregates data from diverse clinical sources including EMRs, ADT systems, patient monitoring systems, and life support devices via various interfaces (e.g., HL7 v2.x, FHIR). Its architecture supports large, data-rich enterprise deployments and can be deployed on hospital servers or a HIPAA-compliant cloud environment. The 'One Click' feature provides direct navigation to the EMR for task execution, optimizing workflow efficiency.

At a glance

Pricing Not publicly disclosed

Deployment Cloud, SaaS

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Details

Category	Clinical Decision Support & Reference, Triage & ER/ICU AI
Pricing	Not publicly disclosed — Enterprise model; custom quote based on the size and scope of the health system deployment.
Deployment	Cloud, SaaS
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated CLEWICU received its initial FDA 510(k) clearance in February 2021 for predicting hemodynamic instability in adult ICU patients, marking the FDA's first clearance for such a device. It also received an Emergency Use Authorization (EUA) in June 2020 for its respiratory deterioration model. Second-generation AI/machine-learning models for predicting patient deterioration received 510(k) clearance in May 2024. The CLEWICU System also received a 510(k) clearance (K233216) with a decision date of March 30, 2026.
Integrations
EHR	Not specified
Specialties	Cardiology, Critical Care, Hospital Medicine

What the Web Says

CLEWICU, developed by CLEW Medical, is an AI-powered predictive analytics solution designed for Intensive Care Units (ICU) to predict patient deterioration, specifically respiratory failure and hemodynamic instability. It has received FDA clearance and Emergency Use Authorization (EUA) for its capabilities, with physicians highlighting its potential for early intervention and reduction of alarm fatigue. The system integrates with existing EHR and patient monitoring systems to provide a unified patient view and real-time physiological profiles.

Overall: Positive

Strengths

FDA-cleared Class II AI medical device.
Proven high accuracy in predictions (5x more accurate than competitors).
Significantly reduces alarm fatigue (up to 50x fewer alarms).
EHR-agnostic for seamless integration across health systems.
Provides early warnings of clinical deterioration (up to 8 hours in advance).
Offers a unified patient view and unit view dashboards.

Limitations

Pricing is not publicly disclosed (enterprise model).
Limited publicly available user reviews or ratings on platforms like G2 and Capterra.
Primary focus is on high-acuity/critical care settings.
May not provide solutions for acute, sudden events as it analyzes developing trends.
System performance is dependent on hospital network communication.
Alerts may be falsely positive or falsely negative.

Based on reviews from: IntuitionLabs.ai, MedTech Dive, CTech, 24X7mag, BioWorld MedTech, PR Newswire, MarkTechPost, FDA, Capterra, G2

Last updated: 2026-07-20

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Press & Coverage

CTech

CLEW Medical receives FDA approval for AI-based tech to support adult ICU patient assessment - CTech

CLEW Medical received FDA approval for its AI-based device, CLEWICU, which predicts hemodynamic instability in adult ICU patients. This marks the first FDA clearance for such a device, following an Emergency Use Authorization for its respiratory model to predict deterioration in COVID-19 patients.

2021-02

BioWorld

Clew Medical receives FDA clearance for ICU device that predicts hemodynamic instability

CLEWICU's predictive system alerts clinicians to patients requiring closer monitoring and identifies those unlikely to deteriorate, reducing alarm fatigue. The system continuously monitors and stratifies patients by risk level to optimize ICU resources.

2021-02

24X7mag

FDA Clears CLEW Medical's AI-Based ICU Solution - 24X7mag

CLEW Medical announced that the FDA granted 510(k) clearance for CLEWICU, its AI-based ICU solution, to predict hemodynamic instability in adult patients. This is the FDA's first clearance for such a device, building on an earlier Emergency Use Authorization for its COVID-19 respiratory deterioration model.

22024-05

Clinical Laboratory News

FDA Clears AI-Based Software That Predicts Hemodynamic Instability in ICU Patients

CLEW Medical received FDA 510(k) clearance for CLEWICU, its AI-based ICU software that predicts hemodynamic instability in adult patients. The system continuously monitors patient risk and provides up to 8 hours advance notification of deterioration, aiding in early intervention and resource management.

2021-04

Medcompare

FDA Clears Clew AI-Based Predictive Analytics for Adult ICU Patient Assessment

The FDA granted 510(k) clearance for CLEWICU, an AI-based ICU solution from Clew Medical, to predict hemodynamic instability in adult patients. This clearance, the first of its kind, follows an EUA for CLEWICU's respiratory deterioration model for COVID-19 patients.

2021-02

PR Newswire

CLEW Medical Receives FDA Clearance for AI-Based Predictive Analytics Technology to Support Adult ICU Patient Assessment - PR Newswire

CLEW Medical announced FDA 510(k) clearance for CLEWICU, its AI-based ICU solution, to predict hemodynamic instability in adult patients. This is the FDA's first clearance for such a device, building on a prior Emergency Use Authorization for its respiratory deterioration model.

2021-02

Business Wire

New Study Finds AI-Driven Prediction Models Accurately Predict Critical Care Patient Deterioration and Significantly Reduce False Alarms for Clinicians - Business Wire

A study published in CHESTu00ae Journal found that CLEW Medical's FDA-cleared AI-driven models for predicting patient deterioration were five times more accurate and generated 50 times fewer alarms than other leading telemedicine systems. The CLEW system provides predictions for respiratory failure and hemodynamic instability.

2024-04

PMC (PubMed Central)

Analysis of Devices Authorized by the FDA for Clinical Decision Support in Critical Care - PMC

A publication in PMC lists the CLEWICU System (ClewICUserver and ClewICUnitor) by Clew Medical Ltd. as an FDA-authorized device for clinical decision support in critical care. It integrates a broad range of data to identify patients at risk of clinical deterioration.

2023-10

Videos

Product demos, reviews, and walkthroughs for CLEWICU.

CLEW

View all on YouTube

Frequently Asked Questions

How does CLEWICU integrate into a physician's workflow and what are its primary clinical applications?

CLEWICU integrates by providing AI-powered predictive analytics for early patient deterioration, such as hemodynamic instability, respiratory failure, and sepsis, up to eight hours in advance. It offers a unified patient view, unit view dashboards, and smart alerting (NotifyMe) to support proactive clinical decision-making in ICUs, Tele-ICUs, EDs, and other inpatient settings.

What regulatory clearances and data security standards does CLEWICU meet?

CLEWICU is an FDA-cleared Class II medical device, having received 510(k) clearance for predicting hemodynamic instability and an Emergency Use Authorization for respiratory deterioration. The platform is also compliant with stringent data security and privacy standards, including HIPAA, ISO 13485, ISO 27001, ISO 27799, and GDPR.

How accurate are CLEWICU's predictions, and what are its key limitations in clinical practice?

CLEWICU's predictive models are reported to be five times more accurate than alerts from leading telemedicine systems, significantly reducing alarm fatigue by generating up to 50 times fewer alarms. However, it is intended as a decision support tool, not a replacement for clinical judgment, and may not identify suddenly occurring acute events as it primarily analyzes developing trends in data.

What are the main differences between CLEWICU and other AI-driven patient monitoring or predictive analytics solutions available?

CLEWICU distinguishes itself with its FDA-cleared AI-powered predictive analytics for specific high-acuity conditions, offering early deterioration detection with high accuracy and significantly reduced alarm fatigue. While other solutions exist, such as Fifth Eye's Analytic for Hemodynamic Instability (AHI), CLEWICU's comprehensive regulatory compliance and proven reduction in false alarms are key differentiators.

How is CLEWICU typically priced for healthcare systems, and is there a transparent pricing model?

CLEWICU operates on an enterprise pricing model, and its pricing is not publicly disclosed. Healthcare systems typically receive a custom quote based on the size and scope of their specific deployment needs.

How does CLEWICU integrate with existing hospital IT infrastructure, such as EHRs and patient monitoring systems?

CLEWICU is designed to be EHR-agnostic and integrates seamlessly with existing electronic health record systems, ADT systems, patient monitoring systems, and life support devices. It collects and aggregates data from these various clinical sources to build a real-time physiological profile for each patient.

Does CLEWICU replace clinical judgment, or is it purely a decision support tool?

CLEWICU is explicitly designed as a decision support tool to augment, not replace, a physician's clinical judgment. It provides predictive insights to assist healthcare providers in making informed decisions for proactive patient care.

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