Etiometry
 | This article has multiple issues. Please help improve it or discuss these issues on the talk page. (Learn how and when to remove these messages)
|
| Etiometry Inc | |
|---|---|
 | |
| Type | Privately held company |
| Industry | Medical Device |
| Founded | 2010 |
| Founder | Jesse Lock, MD, Dimitar Baronov and Evan Butler |
| Headquarters | Boston, MA |
Area served | Worldwide |
| Key people | Dimitar Baronov, Evan Butler and Shane Cooke |
| Products | Etiometry platform |
Number of employees | 50+ |
| Website | https://www.etiometry.com/ |
Etiometry, Inc. is an American medical technology company based in Boston, Massachusetts, founded in 2010. It develops the Etiometry Platform (also known as the T3 Platform), a regulated medical device software system for intensive care units (ICUs). According to product documentation, the platform aggregates real-time physiologic data and employs risk analytics to help clinicians identify early signs of deterioration in pediatric and adult critical care settings. It has received FDA 510(k) clearances, CE marking under EU Medical Device Regulation (MDR), and Health Canada licensing. Peer-reviewed publications have assessed the platform's clinical utility as a clinical decision support system, and published case studies have documented its use in academic intensive care units.
History
Etiometry was founded by Dimitar Baronov, Evan Butler, and Jesse Lock, drawing from collaborations between Boston Children's Hospital and Boston University. The founders applied aerospace engineering principles to ICU data modeling, leading to the creation of the initial T3 platform. Early pilots at Boston Children's and The Hospital for Sick Children (Toronto) informed the platform's design before its commercialization in 2014.
The first FDA 510(k) clearance was secured in March 2015 for the core data visualization module. Later clearances covered advanced risk indices: the IDO2(Inadequate Oxygen Delivery Index) (2016) and IVCO2 (Inadequate Ventilation of CO2) (2019). On February 12, 2025, Etiometry obtained its tenth clearance (510(k) K241479), which combined four indices (IDO2, IVCO2, ACD, and HLA) with cybersecurity compliant with FDA Section 524B, as reported in independent industry media. A further clearance was obtained on April 3, 2026 (510(k) K254066) for the Etiometry Platform under the Special 510(k) pathway.
Platform Technology
The Etiometry Platform combines Data Aggregation and Visualization to integrate continuous data from bedside devices and laboratory systems into a time-sequenced dashboard for clinicians.
Risk Analytics Engine (RAE) computes real-time risk indices using Bayesian models:
According to product documentation and published studies, the platform supports local and remote ICU monitoring.
Independent Clinical Studies
The following published studies have explored the platform's potential role in supporting clinical decision-making in critical care settings.
- IDO2 and Vasoactive Weaning: Critical Care Explorations (2021) multicenter study of over 3,000 pediatric cardiac surgery patients found that high IDO2 was associated with vasoactive drug weaning failure (OR ≈ 4, p < 0.001).
- Extubation Failure: A 2025 cohort study in Pediatric Critical Care Medicine reported that elevated IDO2 and IVCO2 before extubation were associated with increased risk of failure in neonates post-congenital heart surgery (OR ≈ 1.8, p < 0.05).
- Resource Utilization: Observational study at a hospital in Alabama was associated with a reduction in the length of ICU stay and ventilation duration following platform integration.
- Decrease in Duration of Vasoactive Infusions: In a multicenter before-and-after study conducted between June 1, 2020, and December 31, 2022, the platform, was shown to significantly decreased vasoactive infusions duration.
Regulatory Approvals and Certifications
| Authority / Standard | Region | Details |
|---|---|---|
| FDA 510(k) (K241479) | USA | Ten clearances 2015–2025, including 2025 submission that added four analytic indices and cybersecurity improvements under FDA guidance Section 524B. |
| CE Mark (Class IIa, MDR) | EU | Certified for pediatric and adult ICU monitoring under EU MDR. |
| Health Canada MDL | Canada | Licensed as a Class III medical device; maintained through MDSAP audit. |
| ANVISA Registration | Brazil | Registered Class II medical device via MDSAP pathways. |
| ISO 13485:2016 | Global | Certified medical device QMS via MDSAP registry. |
| MDSAP | Global | Verified audit covering FDA, Health Canada, ANVISA. |
| ISO/IEC 27001 | Global | Certified information security management system. |
| SOC 2 Type II | USA | Independent audit of security controls. |
| HIPAA | USA | The platform is designed to satisfy HIPAA requirements. |
| FDA Section 524B Cybersecurity | USA | 2025 clearance aligned with updated cybersecurity rules. |
Adoption and Clinical Use
According to published reports, the platform has been implemented in hospitals in North America, Europe and Asia. Published use cases include cardiac output monitoring post-surgery, extubation decision support, remote ICU monitoring, and automation of hospital-defined protocols for workflows such as breathing trials. The platform archives high-frequency patient data, which has been used in retrospective research and internal model development.
References
- 1 2 3 4 5 "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2025-07-17.
- 1 2 3 4 5 "Etiometry Gains 10th FDA Clearance for Critical Care Platform". Medical Product Outsourcing. 2025-02-27. Retrieved 2025-07-17.
- 1 2 "EUDAMED". ec.europa.eu. Retrieved 2025-07-17.
- ↑ "health-products.canada.ca". Government of Canada/ Medical Devices/ Active licence listing by company. 2025-07-16.
- 1 2 Hames, Daniel L.; Abbas, Qalab; Asfari, Ahmed; Borasino, Santiago; Diddle, J. Wesley; Gazit, Avihu Z.; Lipsitz, Stuart; Marshall, Amanda; Reise, Katherine; Guerineau, Luciana Rodriguez; Wolovits, Joshua S.; Salvin, Joshua W. (May 2025). "Extubation Failure in Neonates Following Congenital Cardiac Surgery: Multicenter Retrospective Cohort, 2017–2020". Pediatric Critical Care Medicine. 26 (5): e590–e599. doi:10.1097/PCC.0000000000003703. ISSN 1947-3893. PMID 39927824.
- 1 2 Goldsmith, AJ (January 2021). "IDO2 index predicts vasoactive weaning failure". Critical Care Explorations. 3 (7): e0487.
- 1 2 3 Clark, Matthew G.; Borasino, Santiago; Zaccagni, Hayden J.; Payne, Shannon; Raper, Justin; Loberger, Jeremy; Hock, Kristal M.; Asfari, Ahmed (February 2025). "Automated spontaneous breathing trial performance tool is associated with improved outcomes following pediatric cardiac surgery: A single-center retrospective study from Alabama, USA". Journal of Pediatric Critical Care. 12 (1): 1–7. doi:10.4103/jpcc.jpcc_60_24. ISSN 2349-6592.
- ↑ Baronov, Dimitar; McManus, Michael; Butler, Evan; Chung, Douglas; Almodovar, Melvin C. (2015). "Next generation patient monitor powered by in-silico physiology". 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). Vol. 2015. pp. 4447–4453. doi:10.1109/EMBC.2015.7319382. ISBN 978-1-4244-9271-8. ISSN 2694-0604. PMC 4754983. PMID 26737282.
- 1 2 Kindle, Ryan D.; Badawi, Omar; Celi, Leo Anthony; Sturland, Shawn (July 2019). "Intensive Care Unit Telemedicine in the Era of Big Data, Artificial Intelligence, and Computer Clinical Decision Support Systems". Critical Care Clinics. 35 (3): 483–495. doi:10.1016/j.ccc.2019.02.005. ISSN 1557-8232. PMID 31076048.
- ↑ "510(k) Premarket Notification K254066". U.S. Food and Drug Administration. Retrieved 2026-05-14.
- ↑ Gazit, Avihu Z.; Futterman, Craig; Baronov, Dimitar; Tomczak, Adam; Goldsmith, Michael P.; Talisa, Victor B.; Nadkarni, Vinay M.; Laussen, Peter C.; Salvin, Joshua W. (July 2025). "Risk Analytics Clinical Decision Support Decreases Duration of Vasoactive Infusions Following Pediatric Cardiac Surgery: A Multicenter Before and After Clinical Trial". Critical Care Medicine. 53 (7): e1355–e1364. doi:10.1097/CCM.0000000000006682. ISSN 1530-0293. PMC 12331254. PMID 40298483.
- ↑ Abbas, Qalab; Hussain, Muhammad Zaid H.; Shahbaz, Fatima Farrukh; Siddiqui, Naveed ur Rehman; Hasan, Babar S. (June 2022). "Performance of a Risk Analytic Tool (Index of Tissue Oxygen Delivery "IDO2") in Pediatric Cardiac Intensive Care Unit of a Developing Country". Frontiers in Pediatrics. 10 846074. doi:10.3389/fped.2022.846074. ISSN 2296-2360. PMC 9203960. PMID 35722489.