BOSTON, March 10, 2025 – CLEW, a leading provider of AI-driven clinical surveillance solutions, today announced the launch of its Sepsis Virtual Unit (SVU), designed to help healthcare organizations improve sepsis detection, enhance SEP-1 compliance, and drive better patient outcomes. The CLEW SVU provides real-time AI-powered monitoring and surveillance, enabling clinicians to detect sepsis earlier, ensure timely interventions, and streamline compliance with evolving regulatory requirements. 

With CMS increasing enforcement of SEP-1 compliance, hospitals now face greater financial penalties and reimbursement risks tied to their adherence to sepsis treatment protocols. Starting in 2024, CMS has linked SEP-1 performance more directly to Value Based Purchasing (VBP) incentives, meaning hospitals that fail to meet compliance standards risk reduced reimbursements and increased financial penalties. Given that sepsis accounts for nearly $62 billion in annual healthcare costs and is a leading cause of hospital mortality, healthcare systems must act swiftly to improve protocol adherence. The CLEW SVU enables hospitals to stay ahead of these changes by offering centralized, real-time monitoring, automated SEP-1 bundle tracking, and actionable insights, helping providers reduce sepsis-related mortality, optimize workflows, and safeguard reimbursements. 

“Sepsis remains one of the leading causes of hospital mortality and costs, and regulatory requirements continue to push for better compliance and outcomes,” said Noa Berger, VP Product at CLEW. “Our Sepsis Virtual Unit provides organizations with the tools they need to detect sepsis earlier, improve protocol adherence, and ultimately save more lives.” 

The CLEW SVU seamlessly integrates with any EMR, ensuring quick adoption without disrupting existing workflows. 

By helping hospitals and healthcare systems stay ahead of SEP-1 regulatory requirements, CLEW’s Sepsis Virtual Unit empowers organizations to deliver higher-quality care, reduce sepsis-related penalties, and improve both clinical and financial outcomes. 

About CLEW 

CLEW provides real-time AI analytics platforms designed to help providers make better-informed clinical decisions by predicting life-threatening complications across various medical care settings. CLEW’s goal is to provide solutions that can improve outcomes and safety, streamline patient care, and efficiently handle regulations and penalties, ultimately lowering the cost of care. Originally developed and proven in the acute care setting, CLEW continues to develop machine learning models that can optimize clinical resources and guide healthcare providers in predicting patient deterioration across all care settings. 

For more information on CLEW’s Sepsis Virtual Unit, visit www.clewmed.com, and on LinkedIn at linkedin.com/company/clewmed/ 

For media inquiries, please contact: 
Izik Itzhakov, VP Business Development 
[email protected] 
 

The open AvaSure Virtual Care ecosystem enables the CLEW AI-powered, FDA-cleared predictive analytics solution for accurate early detection of patient deterioration in critical care

BELMONT, MI and BOSTON, MA – [June 5, 2024] – AvaSure, a market leader in acute virtual care, and CLEW Medical, an AI-enabled clinical surveillance and predictive analytics company, announced their partnership to drive early detection of critical care patient deterioration, leading to more timely interventions, reduced complications, fewer readmissions, and decreased mortality.

“We are thrilled to enhance intensive care units using our virtual care platform by partnering with CLEW’s advanced clinical surveillance solution,” said Adam McMullin, Chief Executive Officer, AvaSure. “AvaSure is dedicated to fostering an open ecosystem for virtual care, ensuring customers can benefit from a single, integrated platform. We continue to add high-value partners so our customers can maximize their investment and deliver high-quality virtual care tailored to the needs of patients at different acuity levels.” 

When hospitals partner with AvaSure, they invest in a platform that fosters a connected ecosystem, allowing for flexibility and adaptability to scale as their needs change.

“CLEW provides the first FDA-cleared predictive analytics solution that responsibly applies AI to advance high-acuity care and improve clinical outcomes for patients,” said Paul Roscoe, CEO, CLEW Medical. “CLEW prediction models have been proven to be five times more accurate, with 50 times fewer alarms, than other leading patient monitoring systems. The partnership between AvaSure and CLEW helps to elevate any virtual nursing assessment by providing the ability to easily validate clinical insights with real-time video analysis.”

The CLEW intelligent clinical surveillance platform enables decision support for complex clinical scenarios and allows providers to anticipate patient deterioration with remarkable accuracy. When deterioration is detected based on real-time patient physiology, the caregiver can validate alerts from CLEW using AvaSure’s virtual care platform, facilitating early intervention whenever a patient needs attention. This leads to improved clinical outcomes for the patient, reduced burden on caregivers, and operational efficiencies for the health system. 

AvaSure and CLEW are at the forefront of healthcare technology innovation. Integrating AvaSure’s leading virtual care platform with CLEW’s cutting-edge, AI-driven clinical surveillance will benefit everyone in the healthcare ecosystem. By harnessing the power of both solutions, hospitals and health systems can improve patient safety, increase caregiver satisfaction, and enhance patient care across the enterprise. 

About AvaSure 

AvaSure® is an intelligent virtual care platform that healthcare providers use to engage with patients, optimize staffing, and seamlessly blend remote and in-person care at scale. The platform deploys AI-powered virtual sitting and virtual nursing solutions, meets the highest enterprise IT standards, integrates seamlessly with technology partners, and drives measurable outcomes. AvaSure consistently delivers a 6x ROI and has been recognized by KLAS Research as the #1 solution for reducing the cost of care. With a team of 15% nurses, AvaSure is a trusted partner of 1,100+ hospitals with experience in over 5,000 deployments. To learn more, visit avasure.com.

About CLEW Medical, Inc. 

CLEW offers the first FDA-cleared, class II medical device, AI-based clinical predictive models for critical care as a part of its intelligent clinical surveillance platform. Its ability to offer accurate, predictive insights around patient deterioration allows health systems to optimize patient interventions, decreasing mortality and reducing complications and readmissions. Its proprietary models offer an optimal balance of precision and sensitivity, which results in fewer high-risk notifications, reducing alarm fatigue amongst providers and clinicians. For more information, visit clewmed.com.

Media contacts:

Marcia Rhodes, Amendola Communications for AvaSure

[email protected]

Sarah Ong, Matter Health for CLEW Medical 
[email protected]

BOSTON, MA, May 13, 2024 – CLEW Medical, a clinical surveillance and predictive analytics company, today announced that its second-generation, AI/machine-learning models for predicting patient deterioration have received 510(k) clearance from the Food & Drug Administration (FDA). This marks a significant milestone for CLEW, following its pioneering FDA clearance as a class II medical device in 2021.

“At CLEW, we understand the significance of using AI to enhance care for critically ill patients,” said Paul Roscoe, CLEW CEO. “We are committed to fostering trust among caregivers, while offering them the most sophisticated and accurate clinical predictions available on the market by adhering to the most stringent regulatory processes. AI and machine-learning technology in this space must undergo the same level of scrutiny and diligence in design, development, testing, and validation as other medical devices used by clinicians.”

Obtaining this FDA 510(k) clearance required CLEW to fulfill all standard prerequisites applicable to medical devices. This involves a thorough assessment of safety and performance data, along with extensive experimentation. The FDA also approved the company’s proposed PCCP (pre-authorized change control plan) to allow certain future changes to the system input data set without needing to file a new 510(k).

Built upon proprietary, machine-learning derived prediction models and rules-based best practices, the CLEW platform offers health systems an early identification of a patient’s risk of deterioration. A recent peer-reviewed study published in CHEST Journal notably found that predictions from the CLEW platform were at least five times more accurate than alerts from the leading telemedicine system and generated 50 times fewer alarms than other monitoring systems. For more information about that study, click here.

For more information about the CLEW system, contact the CLEW team.

About CLEW Medical, Inc.
CLEW offers the first FDA-cleared, class II medical device, AI/ML-based clinical predictive models for critical care as a part of its intelligent clinical surveillance platform. Its ability to offer accurate, predictive insights around patient deterioration allows health systems to optimize patient interventions, decreasing mortality and reducing complications & readmissions. Its proprietary models offer an optimal balance of precision and sensitivity, which results in fewer high-risk notifications, reducing alarm fatigue amongst providers and clinicians.

Media
Matter Health for CLEW Medical
Matt Robbins
T: 617.874.5203
[email protected]

BOSTON, MA, April 29, 2024 – CLEW, a clinical intelligence and predictive surveillance company, today announced the general availability of its FDA-cleared, AI-driven, intelligent clinical surveillance platform. Built upon proprietary, machine-learning derived prediction models and rules-based best practices, the CLEW platform offers health systems an early identification of a patient’s risk of deterioration.

CLEW initially introduced its system of AI-generated prediction models in 2019 to support critical care and telemedicine operations, aiming to enhance patient care in virtual intensive care units (VICUs or Tele-ICUs). Implemented in numerous critical care departments across the United States, including Penn State Health, the system quickly demonstrated its efficacy and CLEW promptly responded to customer demands by expanding its platform to areas such as the emergency department, medical/surgical floors, perioperative suites, and specialty care units.

“As we navigate the complexities of modern healthcare, AI-derived systems emerge as a beacon of innovation, transforming our approach to care delivery,” Paul Roscoe, CLEW CEO shared. “When delivered with meticulous regulatory oversight, AI can unlock new possibilities for precision medicine, early detection, and personalized treatments. Our commitment to integrating AI-driven prediction models into healthcare reflects our dedication to enhancing patient outcomes, driving efficiencies, and ultimately, saving lives.”

Equipped with these advanced clinical insights, caregivers can focus on delivering exceptional patient care at the highest level of their licensure. The CLEW system empowers care teams to intervene proactively in identifying high-risk patients up to eight hours before physiological signs and other monitoring systems would indicate. This leads to lower mortality rates, decreased complications, and fewer readmissions. As a result, proactive and timely care mitigates unforeseen bottlenecks, reduces length of stay and improves overall capacity.

In addition to CLEW’s robust prediction models, its platform includes built-in, best practice clinical protocols. They are easily customizable, allowing health systems to add their own standard practices for consistent deployment of specific care plans. With its NotifyMe solution, caregivers can receive tailored multi-parameter smart alerts, specifically designed to pinpoint urgent and complex clinical scenarios. Clinicians have the flexibility to determine which attributes and clinical criteria are crucial for monitoring and personalize the configuration.

The CLEW platform also includes prediction-driven clinician-centric tools designed to reduce nursing fatigue, including a real-time, priority-driven patient worklist developed in collaboration with nurses at Penn State Health. Since going live with the platform, the critical care team at Penn State has integrated the use of CLEW into their daily workflow.  

A recent peer-reviewed study published in CHEST Journal, notably found that predictions from the CLEW platform were at least five times more accurate than alerts from the leading telemedicine system and generated 50 times fewer alarms than other monitoring systems. More information about that study, click here.

For more information about the CLEW system, contact the CLEW team.

About CLEW Medical, Inc.
CLEW offers the first FDA-cleared, class II medical device, AI-based clinical predictive models for critical care as a part of its intelligent clinical surveillance platform. Its ability to offer accurate, predictive insights around patient deterioration allows health systems to optimize patient interventions, decreasing mortality and reducing complications & readmissions. Its proprietary models offer an optimal balance of precision and sensitivity, which results in fewer high-risk notifications, reducing alarm fatigue amongst providers and clinicians. For more information, visit clewmed.com.

Media
Matter Health for CLEW Medical
Matt Robbins
T: 617.874.5203
[email protected]

Boston, MA (April 26, 2024) – CLEW, a clinical intelligence and predictive surveillance company, announced today that it has been named to Newsweek’s list of the World’s Best Digital Health Companies for 2024 within the Data Analytics category. This prestigious award was presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider.

“We’re honored to be part of Newsweek’s World’s Best Digital Health Companies, as it provides further validation of our technology’s transformational capabilities,” said Paul Roscoe, CEO of CLEW. “At CLEW, we believe AI that is rigorously trained, – clinically validated and regulated has the capacity to revolutionize the future of care delivery. By leveraging machine learning-based prediction models and rules-based best practices, clinicians can focus on delivering top-of-license care, leading to better patient outcomes.”

The World’s Best Digital Health Companies 2024 ranking lists the top 400 companies from over 35 different countries. The winners were ranked across seven market segments: Data Analytics, Diagnostics, Health Records, Medical Management, Prevention, Telehealth and Treatment.

The top list is based on three pillars: financial performance, impact and online engagement. For each area, Statista analyzed data from a range of sources assessing each company’s financial strength, expertise of the leadership team and quality of its product or service as well as engagement by users:

• Financial Performance: Statista analyzed financial data from publicly available sources. CLEW’s platform is now deployed at a growing number of US hospitals from large academic teaching hospitals to rural community hospitals. New deployments are also being brought on-line in European hospitals.
  
  
• Impact: Statista cooperated with data and market intelligence company HolonIQ to assess a company in different impact dimensions, encompassing factors such as the quality and uniqueness of their product/service, as well as the expertise of their leadership team. CLEW’s system of AI-derived models for predicting patient deterioration is the first of its kind to achieve FDA clearance as a class II medical device. The novel system has also been proven in a peer-reviewed study to be five times more accurate and generate 50-times fewer alarms than other telemedicine and bedside monitoring systems.
  
  
• Online Engagement: Statista analyzed traffic data from company websites and apps to assess the engagement of users with their product/service.
  

Statista publishes hundreds of worldwide industry rankings and company listings with high-profile media partners. This research and analysis service is based on the success of statista.com, the leading data and business intelligence portal that provides statistics, relevant business data, and various market and consumer studies and surveys.

About CLEW Medical, Inc.

CLEW offers the first FDA-cleared, class II medical device, AI-based clinical predictive models for critical care as a part of its intelligent clinical surveillance platform. Its ability to offer accurate, predictive insights around patient deterioration allows health systems to optimize patient interventions, decreasing mortality and reducing complications & readmissions. Its proprietary models offer an optimal balance of precision and sensitivity, which results in fewer high-risk notifications, reducing alarm fatigue amongst providers and clinicians. For more information, visit clewmed.com.

Media
Matter Health for CLEW Medical
Matt Robbins
T: 617.874.5203
[email protected]

Boston, MA, April 8, 2024 – A scientific paper recently published by CHEST Journal, shares a study that finds CLEW Medical’s FDA-cleared AI-driven models for predicting patient deterioration were five times more accurate than alerts from a leading telemedicine system using data from two major US health systems.

The study was conducted in ICUs by renowned critical care leaders, Craig Lilly, MD, Vice Chair of Critical Care at UMass Memorial Medical Center and David Kirk, MD, Chief Clinical Integration Officer at WakeMed Health & Hospitals, with support from CLEW advisory board physicians and data science experts. The prediction models used in the study are a part of CLEW’s intelligent clinical surveillance platform. The study compared performance of this novel system to the accuracy and utility of alerts in the most widely utilized telemedicine and bedside monitoring systems.

The CLEW system, which notifies clinical staff that a patient is likely to deteriorate up to eight hours before other monitoring systems would indicate, creates opportunities for early intervention, which decreases complications and mortality. The study describes that “the transformation of even a small number of emergent responses to physiological instability events… would be expected to meaningfully improve ICU care delivery.” CLEW’s models provide predictions for high and low risk of respiratory failure and hemodynamic instability, two of the most common conditions affecting patient status in intensive care.

With notification that a patient is at high-risk of one of these situations, caregivers have time to intervene in advance of physiological signs of deterioration. This can help them potentially avoid emergency interventions, such as the use of a ventilator for acute respiratory distress. It also supports the health system with capacity management, by providing early identification of potential bottlenecks caused by unexpected deterioration.

In addition to demonstrating its superior accuracy, the study concluded that the CLEW system generated 50-times fewer alarms than other leading systems. In busy and overburdened critical care environments, this can greatly reduce alarm fatigue and the associated cognitive burden on caregivers. Fewer alarms mean fewer interruptions, which as the study notes “creates a more calm and peaceful ICU environment.” The study found that on average, 98 percent of bedside monitoring alarms (147 of 150 per patient day) were false positives. Due to its less frequent interruptions and greater accuracy, it concluded that the use of the CLEW system “is one of the few available options that improves ICU burnout syndrome by reducing unnecessary workload.”

The innovative CLEW system is the first of its kind to be cleared by the FDA as a class II medical device. It is currently in use at a number of leading academic and health system networks.

Download a summary of the study

About CLEW Medical, Inc.

CLEW offers the first FDA-cleared, class II medical device, AI-based clinical predictive models for critical care as a part of its intelligent clinical surveillance platform. Its ability to offer accurate, predictive insights around patient deterioration allows health systems to optimize patient interventions, decreasing mortality and reducing complications & readmissions. Its proprietary models offer an optimal balance of precision and sensitivity, which results in fewer high-risk notifications, reducing alarm fatigue amongst providers and clinicians.

Media
Matter Health for CLEW Medical
Matt Robbins
T: 617.874.5203
[email protected]

Key Takeaways:

• A deep dive into the innovative capabilities of CLEW AI’s predictive analytics.
• The strategic synergy between CLEW AI and Equum Medical and how it sets the gold standard for acute telehealth care.
• Economic perspectives: Unveiling cost savings and ROI projections in integrating AI into telehealth services.

Why You Should Download:
Whether you are a healthcare professional, technology enthusiast, or an investor, understanding the integration of AI in high-acuity telehealth care is crucial in the modern healthcare landscape. This white paper will equip you with the knowledge and insights needed to stay at the forefront of telehealth advancements.

Boston, MA, February 1, 2023 – CLEW, a provider of real-time AI analytics platforms for healthcare providers, announced the launch of the CLEW ICU Conversion and Accelerator program. The program includes CLEW’s FDA-cleared AI predictive models, the CLEW ICU workflow platform, and packaged integrations to EMR, monitoring, and AV equipment. In addition, the program includes consulting and implementation resources that will allow health systems in the US to seamlessly migrate from the Philips eICU® software within 12 weeks.

“As they evaluate transitioning from their legacy Tele-ICU solutions, healthcare providers have increasingly reached out to CLEW. They recognize that CLEW provides a next-generation solution with new capabilities and want assurance that the migration can be achieved rapidly with minimal disruption to their Tele-ICU operations,” said Paul Roscoe, CEO of CLEW.

The Conversion and Accelerator program includes a pre-built integration hub that significantly reduces the IT resources required to install and maintain the EMR and patient bedside monitoring interfaces. Already deployed at hospitals using the Epic and Cerner EMRs, the CLEW integration hub can be configured to accept the same data flows as those already sent to the legacy Tele-ICU system.

“We appreciate the financial challenges that health systems are currently facing, and so we are also announcing an innovative way to finance the deployment of CLEW ICU with minimal upfront capital and operating outlays during the first year,” continued Roscoe.

The first of its kind to be granted 510(k) clearance, CLEW Virtual ICU leverages advanced AI technology to identify patients that are most and least likely to deteriorate in the near future and streamlines workflow to improve communications, decision-making, and care delivery. Healthcare systems such as Penn State Health use the system’s powerful technology to potentially improve clinical outcomes, lower costs, and enhance the provider, patient, and family experience.

About CLEW:

CLEW provides real-time AI analytics platforms designed to help providers make better-informed clinical decisions by predicting life-threatening complications across various medical care settings. CLEW’s goal is to provide solutions that can improve outcomes and safety, streamline patient care, and efficiently handle regulations and penalties, ultimately lowering the cost of care. Originally developed and proven in the ICU, CLEW will develop machine learning models that have the potential to optimize clinical resources and guide healthcare providers in predicting patient deterioration across all care settings.

Connect with us at www.clewmed.com, on LinkedIn at www.linkedin.com/company/clewmed/, on Facebook at www.facebook.com/CLEWMedical/ and on Twitter @CLEWMedical.

Previously, Mr. Roscoe served as the CEO of Crimson, a division of the Advisory Board Company, and led the business to become the de-facto standard healthcare analytics company in the US healthcare market. Before Crimson, he was General Manager of Microsoft’s Healthcare Solutions Group. Mr. Roscoe joined Microsoft after the acquisition of Sentillion, where he served as President and led the business to become the industry leader in Healthcare Identity Management. Throughout his career, Mr. Roscoe has held numerous executive and management roles at healthcare technology companies, including VisionWare Inc., Sybase, and New Era of Networks (acquired by Sybase).

About CLEW:

CLEW provides real-time AI analytics platforms designed to help providers make better informed clinical decisions by predicting life-threatening complications across various medical care settings. CLEW’s goal is to provide solutions that can improve outcomes and safety, streamline patient care, and efficiently handle regulations and penalties, ultimately lowering the cost of care. Originally developed and proven in the ICU, CLEW will develop machine learning models that have the potential to optimize clinical resources and guide healthcare providers in predicting patient deterioration across all care settings.

Connect with us at www.clewmed.com, on LinkedIn at www.linkedin.com/company/clewmed/, on Facebook at www.facebook.com/CLEWMedical/ and on Twitter @CLEWMedical.