Etiometry Achieves 10th FDA Clearance for Critical Care Platform

FDA Clearance Solidifies Etiometry’s Regulatory Leadership and Cybersecurity Excellence

BOSTON--(BUSINESS WIRE)--As cybersecurity threats in healthcare continue to rise, and with the U.S. Food and Drug Administration (FDA) implementing stricter guidelines for cybersecurity compliance, Etiometry, the leader in clinical decision support software for high-acuity units, has received its 10th FDA clearance. This milestone underscores the company's commitment to driving innovation in clinical decision support while meeting the highest cybersecurity and regulatory standards.

With the FDA’s recent emphasis on cybersecurity as a critical component of medical device and software safety, obtaining clearance is more vital than ever. The latest enhancements to the Etiometry Platform not only improve patient monitoring and clinical decision support but also ensure compliance with the FDA’s heightened security requirements. The result is to protect hospitals and patients from evolving cyber threats.

“This clearance both reinforces Etiometry’s leadership in clinical decision support and regulatory compliance while also affirming our dedication to cybersecurity,” said Shane Cooke, CEO of Etiometry. “With hospitals facing unprecedented cybersecurity risks, it is imperative that they vet all technology vendors to ensure they meet the FDA’s latest, most rigorous security standards. Adopting solutions that have not been scrutinized under these updated guidelines exposes hospitals to unnecessary vulnerabilities. At Etiometry, we remain steadfast in our mission to provide solutions that drive better patient outcomes while safeguarding hospital systems and sensitive patient data.”

As the healthcare industry navigates increasingly complex regulatory and security landscapes, Etiometry’s continued focus on FDA-cleared innovation ensures hospitals can confidently deploy technology that meets the highest standards in clinical excellence and cybersecurity resilience.

Next-Generation Cybersecurity and Compliance

With this clearance, Etiometry has ensured that its platform aligns with the FDA's latest cybersecurity guidance in the following respects:

• Fortified Data Protection: Enhanced safeguards against cybersecurity risks, reinforcing patient data security.
• Seamless Interoperability: Strengthened and secure integration with medical devices and electronic medical records (EMRs).

Platform Enhancements That Elevate Patient Care

With this clearance, Etiometry enhances both its Data Aggregation & Visualization (DAV) and Risk Analytics Engine (RAE) modules in the following respects:

Advancements in Date Aggregation:

• Enabling institutions to define and standardize clinical workflows, improving efficiency and reducing variability in care.
  • Allows integration of near real-time and retrospective waveform analysis for deeper clinical insight.
  • Seamless HL7 & FHIR compatibility for enhanced electronic medical record (EMR) data exchange.

Advancements in the RAE Module:

• Merging FDA-cleared models for Adult and for Pediatric patients into a single, comprehensive framework for optimized clinical decision-making.
• Smarter Algorithms based on additional data types and with superior predictive accuracy.
• Expansion of the IVCO₂ algorithm to patients under 29 days old.

About Etiometry

Founded in 2010, Etiometry is a leader in clinical decision-support software designed to help clinicians in intensive care units make data-driven, proactive decisions. By leveraging advanced analytics and AI-powered insights, the company empowers care teams to detect subtle changes in patient conditions, prevent complications, and improve recovery times.

Etiometry has received 10 FDA clearances, and is trusted by leading healthcare institutions worldwide, including top-ranked academic medical centers and pediatric hospitals. The company is committed to advancing patient safety, improving clinical efficiency, and lowering the cost of care through smarter data utilization.

To learn more, visit www.etiometry.com.