Etiometry Gains 10th FDA Clearance for Critical Care Platform

Etiometry, a company specializing in clinical decision support software for high-acuity units, has earned its tenth U.S. Food and Drug Administration (FDA) clearance.

The latest clearance ensures that Etiometry’s platform aligns with the FDA’s latest cybersecurity guidance. It has enhanced safeguards against cybersecurity risks to reinforce patient data security. It also features strengthened and secure integration with medical devices and electronic medical records (EMRs).

The platform also gained advancements in data aggregation. It allows integration of near real-time and retrospective waveform analysis for deeper clinical insight. Seamless HL7 & FHIR compatibility enhance EMR data exchange.

Advancements were made in the Etiometry platform’s RAE module, as well. It merges FDA-cleared models for adult and pediatric patients into a single, comprehensive framework for optimized clinical decision-making. Smarter algorithms are based on additional data types with enhanced predictive accuracy, and its IVCO₂ algorithm was expanded to patients under 29 years old.

“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.”