Etiometry has received its 10th FDA clearance.
RT’s Three Key Takeaways:
- FDA Cybersecurity Compliance – Etiometry has secured its 10th FDA clearance.
- Enhanced Platform Security – The Etiometry Platform now features fortified data protection, seamless device-EMR interoperability, and compliance with updated FDA cybersecurity guidance to safeguard hospitals and patients from evolving threats.
- Clinical Decision Support Innovation – Platform upgrades include improved Data Aggregation & Visualization workflows, integration of real-time waveform analysis, and a unified Risk Analytics Engine with smarter predictive algorithms for both adult and pediatric patients.
As cybersecurity threats in healthcare continue to rise, and with the US FDA implementing stricter guidelines for cybersecurity compliance, Etiometry has received its 10th FDA clearance.
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.
