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Study published in the New England Journal of Medicine AI Concludes that the Sepsis ImmunoScore™, the First FDA-Authorized AI Tool for Sepsis, has both significant Diagnostic and Predictive Power

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Groundbreaking NEJM AI Study Highlights the Ability of Prenosis’ Sepsis ImmunoScore™ to Holistically Predict Adverse Outcomes, Ushering in a New Era of Predictive Sepsis Tools Powered by AI

CHICAGO, Dec. 4, 2024 /PRNewswire/ — A new study published in the New England Journal of Medicine AI (NEJM AI) concluded the Sepsis ImmunoScore™, the first FDA-authorized AI diagnostic for sepsis, has high accuracy for the diagnosis of sepsis and for prediction of key adverse patient outcomes, concretely demonstrating the benefit of AI to inform sepsis care. Sepsis, an overactive immune response to infection, costs the U.S. healthcare system billions of dollars annually and claims the lives of at least 350,000 people each year—more than all cancers combined.

The peer-reviewed study—FDA-Authorized AI/ML Tool for Sepsis Prediction: Development and Validation—found the Sepsis ImmunoScore™ has high accuracy for sepsis diagnosis and simultaneously predicted critical outcomes, including mortality during hospitalization, length of stay before discharge, ICU admission, need for mechanical ventilation, and use of vasopressors. This represents the first time an FDA-authorized tool for sepsis can predict all of these critical outcomes simultaneously.

This milestone publication underscores the potential of Prenosis Inc.’s Sepsis ImmunoScore™ to transform sepsis management by presenting providers with trustworthy predictive information, allowing them to shift from a reactive to a proactive approach to care.

While single biomarkers, such as Procalcitonin (PCT), have been valuable tools in diagnosing sepsis for over two decades, they have limitations when trying to predict the future. The study demonstrated the combination of multidimensional inputs—vital signs, lab data, and sepsis-specific biomarkers—into a comprehensive AI-driven tool provides more reliable diagnostic information and is predictive of future patient outcomes.

“The Sepsis ImmunoScore™ is the first FDA-authorized sepsis AI algorithm that functions by embedding in the EMR and is approved to aid providers in the identification and assessment of patients with sepsis,” said Nathan I. Shapiro, MD, MPH, a Professor of Emergency Medicine at Harvard Medical School and attending physician in the Department of Emergency Medicine at Beth Israel Deaconess Medical Center, and the paper’s corresponding author1.

“For too long, clinicians have struggled with the early and accurate prediction of adverse outcomes due to sepsis, a complex, rapidly progressing condition,” said Bobby Reddy, Jr., Prenosis Co-Founder and CEO. “By delivering FDA validated AI results with transparency and explainability for clinicians, tools like the Sepsis ImmunoScore™ offer critical insights to improve patient outcomes.”

“Hospitals and clinicians now have access to the first-ever FDA-authorized, peer-reviewed AI solution that provides unmatched insights into sepsis risk and prediction of the negative outcomes associated with sepsis,” said Akhil Bhargava, the study’s lead author. “This study confirmed that AI, when validated, can be a reliable, comprehensive tool to assist providers with identification of patients at high risk of sepsis and prediction of sepsis-related adverse outcomes,” added Bhargava, Prenosis’ Senior Data Scientist — Applied Machine Learning.

About the Sepsis ImmunoScore™

FDA-authorized via the De Novo pathway in April 2024, the Sepsis ImmunoScore™ outputs a combination of both diagnostic and predictive information previously unavailable in a legally marketed device for sepsis. Unlike early warning systems that alert clinicians to potential sepsis with high amounts of false positives, leading to alert fatigue, the Sepsis ImmunoScore™ delivers actionable and trustworthy insights. The Sepsis ImmunoScore™ works in concert with a clinician’s suspicion of serious infection, providing information exactly when needed for decision-making.

The Sepsis ImmunoScore™ was built using Prenosis’ Immunix™ platform, which enables precision medicine in acute care. Immunix™ facilitates the development and validation of new precision solutions, such as AI biomarkers, and their real-time implementation. Over a decade of collaboration with more than ten U.S. partner hospitals, Prenosis used Immunix™ to build a proprietary biobank and dataset of over 113,000 blood samples from more than 28,000 patients. Prenosis merges biological data extracted from these samples with clinical information from Electronic Medical Records, creating the world’s largest biological-clinical dataset for acute care patients with suspected serious infections. This dataset enables the development of AI algorithms to detect rapid immune responses and recommend personalized therapies in real time in hospitals and emergency departments.

About Prenosis

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care.  We believe healthcare should be tailored to individual biology. Our data-driven approach to fast-moving biology in acute care is ushering in a new era of precision medicine. Powered by our Immunix™ precision medicine platform, we generate proprietary biological insights that drive the development of precision products and enable real-time delivery of optimal therapy. With Immunix™, we created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™.

For more information, visit: www.prenosis.com

1 Disclosure: Shapiro holds private equity in and consults for Prenosis.

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HelloNation Article Highlights Sterile Compounding and Medication Safety With Insights From Compounding Pharmacist Expert Laura Temple

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The article explains how sterile compounded medications are prepared to reduce the risk of contamination and support safe, customized treatments.

AZLE, Texas, July 21, 2026 /PRNewswire/ — What does sterile compounding mean for medication safety? HelloNation has published an article explaining how sterile compounding helps pharmacies prepare highly specialized medications while adhering to strict contamination-prevention procedures.

The article features insights from Laura Temple, Compounding Pharmacist Expert and Owner of Laura’s Pharmacy in Azle, Texas. It explains that sterile compounding is a specialized process for preparing medications in carefully controlled environments designed to reduce the risk of contamination. Sterile compounded medications are often used for injections, eye drops, IV medications, and other therapies that require the highest levels of cleanliness and precision.

The HelloNation article explains that sterile compounded medications differ from commercially manufactured drugs because they are prepared individually for a patient’s unique medical needs. Physicians may prescribe compounded prescriptions when a patient requires a customized dosage, a combination medication, or a treatment not commercially available. Because these medications often bypass the body’s natural defenses, medication safety depends on strict preparation standards throughout the compounding process.

The article describes how pharmacies that provide sterile compounding rely on cleanroom environments equipped with filtered-air systems, specialized equipment, and contamination-prevention protocols. Pharmacists and technicians follow detailed gowning, sterilization, and handwashing procedures before handling medication ingredients. These measures are designed to support medication safety by limiting exposure to bacteria, particles, and other contaminants.

According to the article, environmental monitoring also plays a critical role in sterile compounding. Temperature control, air quality testing, and routine equipment inspections help maintain consistent preparation standards. The article notes that sterile compounded medications may undergo additional quality assurance checks before being dispensed to patients. These procedures help support both treatment effectiveness and patient safety.

The HelloNation article also explains that pharmacies performing sterile compounding are expected to follow USP guidelines established for sterile preparation. These USP guidelines outline requirements for cleanroom pharmacy operations, environmental testing, employee training, and quality assurance practices. The article emphasizes that maintaining compliance with USP guidelines helps reinforce contamination prevention and consistent preparation standards for compounded prescriptions.

Patients seeking sterile compounded medications may also look for pharmacies that participate in accreditation programs or are overseen by state boards. The article explains that these programs review safety procedures, documentation practices, and facility standards to help maintain medication safety. Regular environmental monitoring and staff competency evaluations are also identified as important safeguards in sterile compounding operations.

The article further explains that communication between pharmacists, healthcare providers, and patients remains an important part of safe compounded prescriptions. Compounding pharmacists review prescriptions carefully, confirm dosing instructions, and evaluate ingredient compatibility before preparation begins. This collaborative approach supports medication safety by reducing the risk of errors and ensuring treatments meet individual patient needs.

The article concludes that sterile compounding continues to play an important role in healthcare, particularly for patients requiring customized therapies that are unavailable through traditional manufacturing channels. Whether preparing IV medications, injectable therapies, or other sterile compounded medications, pharmacies rely on contamination prevention procedures and strict preparation standards to support patient care. The article notes that understanding how sterile compounding works can help patients feel more informed about the safety measures involved in preparing specialized medications.

What Sterile Compounding Means for Medication Safety features insights from Laura Temple, a compounding pharmacist expert at Laura’s Pharmacy in Azle, Texas, on HelloNation.

About HelloNation

HelloNation is America’s Good News Network, a premier media platform built on the idea that good news travels faster when real people tell real stories. Through its community-focused publications and innovative “edvertising” approach, HelloNation delivers content that informs, inspires, and spotlights the leaders making a meaningful impact in their communities.

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CIOs Forced to Rethink Manual Compliance Processes as Regulatory Complexity Rises, Says Info-Tech Research Group

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Regulatory demands are increasing in volume, complexity, and speed, leaving many organizations reliant on fragmented, manual approaches that slow response times and increase risk. New insights from Info-Tech Research Group show that organizations need to adopt more structured and scalable approaches to keep pace with regulatory change. The firm’s recently published blueprint, Build a Regulatory IT Response Engine, provides frameworks, tools, and step-by-step guidance to help organizations translate regulatory requirements into actionable IT controls and prioritized initiatives.

ARLINGTON, Va., July 21, 2026 /PRNewswire/ — Growing regulatory pressure across jurisdictions is forcing organizations to rethink how they interpret, prioritize, and execute compliance requirements. Many IT teams continue to operate with inconsistent processes and limited coordination, resulting in delayed initiatives and increased exposure to financial and reputational risk. Info-Tech’s blueprint, Build a Regulatory IT Response Engine, introduces a coordinated and repeatable approach to help IT leaders operationalize compliance and improve execution outcomes.

Info-Tech’s findings indicate that while organizations recognize the need for faster and more consistent regulatory response, they continue to face barriers such as fragmented interpretation of requirements, weak prioritization, and limited scalability. AI-enabled tools can help streamline analysis and accelerate response planning, but without a coordinated approach grounded in governance and human oversight, those benefits are difficult to realize.

“Regulatory response is becoming too complex to manage through disconnected, manual processes,” says Ahmad Jowhar, senior research analyst at Info-Tech Research Group. “IT leaders need a repeatable way to interpret requirements, prioritize action, and use AI to accelerate planning without losing the governance and oversight needed to execute effectively.”

Key Challenges IT Leaders Face in Regulatory Response

Despite ongoing investments in compliance, organizations continue to face systemic challenges that hinder effective execution. Info-Tech’s blueprint highlights several areas where IT and compliance leaders struggle most:

Fragmented and manual processes that slow regulatory interpretation and response.Inconsistent application of regulatory requirements across teams and jurisdictions.Poor prioritization of IT initiatives, leading to missed deadlines and duplicated effort.Limited scalability to manage increasing regulatory volume and complexity.Misalignment between compliance activities and broader business priorities.

Info-Tech’s Framework for Building a Regulatory IT Response Engine

To address these challenges, Info-Tech recommends a structured, AI-enabled approach that improves consistency, speed, and scalability. The firm’s Build a Regulatory IT Response Engine blueprint outlines the following key priorities for IT leaders:

Define the regulatory landscape: Establish organizational context, governance structures, and a centralized inventory of applicable regulations.Translate requirements into IT controls: Use AI-enabled analysis and structured assessments to convert regulatory obligations into actionable controls.Prioritize IT initiatives: Align initiatives based on cost, effort, impact, and regulatory timelines to reduce execution risk.Build and communicate a roadmap: Develop a clear, resource-aligned roadmap to guide execution and stakeholder alignment.Establish a repeatable process: Continuously monitor, adapt, and refine regulatory response capabilities to maintain compliance over time.

Organizations that adopt this structured approach can move from reactive compliance efforts to a more proactive and scalable model that shortens response timelines, reduces manual effort, and strengthens execution.

The firm’s Build a Regulatory IT Response Engine blueprint includes practical tools such as a Regulation Inventory Tool, a Regulatory Response IT Action Plan Tool, a Communication Deck Template, and a Compliance Program Framework. By applying these resources, IT leaders can standardize regulatory responses, improve prioritization, and help ensure compliance initiatives are executed on time and in alignment with business priorities.

For exclusive and timely commentary from Info-Tech’s experts, including Ahmad Jowhar, and access to the complete Build a Regulatory IT Response Engine blueprint, please contact pr@infotech.com.

About Info-Tech Research Group

Info-Tech Research Group is the “get things done” partner for over 30,000 IT, HR, and marketing leaders worldwide. The fastest growing research and advisory firm, Info-Tech enables leaders to make well-informed decisions and transform their organizations through AI, strategic foresight, step-by-step methodologies, practical tools, industry-leading advisory, and training programs. For nearly 30 years, tens of thousands of private and public organizations have trusted Info-Tech to lead their most important initiatives through periods of change and deliver outcomes that truly matter.

To learn more about Info-Tech’s HR research and advisory services, visit McLean & Company, and for data-driven software buying insights and vendor evaluations, visit the firm’s SoftwareReviews platform.

Media professionals can register for unrestricted access to research across IT, HR, and software and hundreds of industry analysts through the firm’s Media Insiders program. To gain access, contact pr@infotech.com.

For information about Info-Tech Research Group or to access the latest research, visit infotech.com and connect via LinkedIn and X.

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SOURCE Info-Tech Research Group

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Atomera to Announce Second Quarter 2026 Financial Results and Host Webinar on Tuesday, August 4, 2026

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LOS GATOS, Calif., July 21, 2026 /PRNewswire/ — Atomera Incorporated (NASDAQ: ATOM), a semiconductor materials and technology licensing company, announced today that it plans to release its second quarter 2026 financial results after the market closes on Tuesday, Aug. 4, 2026.

The company will host a live video Zoom webinar at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) on Tuesday, Aug. 4, 2026, to discuss the results. The live webinar can be accessed through Atomera’s investor relations website at https://ir.atomera.com. A replay of the webcast will be available for 12 months. To pre-register for the webinar, use the following link.

https://atomera.zoom.us/webinar/register/WN_OJFbTWe1SIyV69LLdDadCw

About Atomera

Atomera Incorporated is a semiconductor materials and technology licensing company focused on deploying its proprietary, silicon-proven technology into the semiconductor industry. Atomera has developed Mears Silicon Technology™ (MST®), which increases performance and power efficiency in semiconductor transistors. MST can be implemented using equipment already deployed in semiconductor manufacturing facilities and is complementary to other nano-scaling technologies already in the semiconductor industry roadmap.  More information can be found at www.atomera.com 

 

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SOURCE Atomera Incorporated

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