Regulatory-grade device evidence reimagined with new precision data from Truveta
Unique device identifier data linked with ADT and chargemaster data give medical device manufacturers unmatched visibility into device use, safety, and outcomes—accelerating regulatory submissions, discovering safety signals faster, and speeding innovation that shapes guidelines and standards of care.
BELLEVUE, Wash., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Truveta today announced a major expansion of its real-world device data capabilities, giving device manufacturers and regulators the most complete, clinically rich view of medical device performance ever available. By linking unique device identifier (UDI) data with minute-level admission–discharge–transfer (ADT) and chargemaster data, Truveta delivers the full picture of when, how, and in what context devices are used—accelerating regulatory submissions, health economics and outcomes research (HEOR), safety monitoring, and more.
Raising the bar for device real-world evidence (RWE)
Truveta is the leading real-world data source built on daily updated, complete, representative, and research-ready electronic health record (EHR) data from US health systems. Linked with closed claims for instant access to a complete, longitudinal view of care, Truveta enables more precise and efficient research on device use, safety, and outcomes.
Unlike billing-only focused data sources, Truveta captures the full patient journey—from pre-diagnosis through surgery and recovery—with outcomes drawn from structured EHR data, clinical notes, images, claims, and mortality data. In fact, Truveta Data provides both device records and clinical notes for more than 10 million patients. With UDI-level detail, minute-level timestamps, and full procedural context, Truveta provides the unmatched precision needed to understand real-world device performance.
“Device companies have long had to choose between chargemaster data with cost visibility but little context, or EHR data with context but incomplete billing data,” said Michael Simonov, MD, Senior Vice President of Product at Truveta. “Truveta is the first to bring both together—device identity, procedural detail, outcomes, and cost—in a single, research-ready dataset trusted by regulators. With down to the minute, down to the millimeter precision, no one else can deliver this level of completeness and detail.”
Key device-specific data uniquely available in Truveta Data include:
- Regulatory-grade UDI integration—Truveta’s proprietary AI normalization—the Truveta Language Model (TLM)—maps device data from structured and unstructured EHR data to FDA’s GUDID database and Truveta’s device hierarchy, capturing brand, model, lot, and expiration date with full procedural context, making more than 300,000 UDIs available across more than 27,000 brands for study.
- Minute-level ADT precision—Admission-discharge-transfer data enable researchers to precisely time-align device use with surgical events, recovery trajectories, ICU transfers, and discharge events to reveal efficiency, safety, and workflow patterns.
- Chargemaster data with clinical linkage—By connecting every billed service, supply, and device directly to the clinical encounter, the combination of chargemaster and deep EHR data enables robust health economics and outcomes research (HEOR), cost-effectiveness, and market access evidence without the bias of billing-only datasets.
- Integrated multi-modal data—With structured EHR data, clinical notes, images, surgical logs, claims, and mortality records, researchers can generate the most comprehensive device-level real-world evidence. For example, images enable researchers to see where a device was placed, how well it’s working, and visually confirm the data insights. More than 5 million patients with both a device record and associated imaging are available in Truveta Data today.
- Device-related procedure data—The new procedure log details provide unmatched visibility into surgical workflows and providing a precise view of how, when, and in what context devices are used. By integrating timestamped surgical logs, supply usage, and extracted clinical notes, procedure logs offer regulatory-grade insight that billing data can’t.
For example, in combining these new procedure-level details and other new data elements with the millions of echocardiogram and cardiac catheterization reports already available in Truveta Data, Truveta continues to be the leader in real-world data for cardiovascular research.
“Truveta Data gave us the granularity we needed to move beyond broad comparisons and start evaluating the safety and efficacy of individual design variations; insights that were previously out of reach,” said George Miller, Director of Clinical Affairs, Medcomp.
To learn more about Truveta Data, visit https://www.truveta.com/Truveta-Data.
To learn more about how to study medical devices using Truveta Data, visit https://www.truveta.com/resources/whitepaper/raising-the-standard-for-device-evidence/.
About Truveta
Truveta is a real-world intelligence company transforming medical science with unprecedented data and predictive AI. We power breakthrough discoveries, accelerate regulatory-grade evidence, and unlock real-time insights from a dataset uniquely built with and owned by US health systems—united by a mission of Saving Lives with Data.
Truveta membership includes Providence, Advocate Health, Trinity Health, Tenet Healthcare, Northwell Health, AdventHealth, Baptist Health of Northeast Florida, Baylor Scott & White Health, Bon Secours Mercy Health, CommonSpirit Health, Hawaii Pacific Health, HealthPartners, Henry Ford Health System, HonorHealth, Inova, Lehigh Valley Health Network, MedStar Health, Memorial Hermann Health System, MetroHealth, Novant Health, Ochsner Health, Premier Health, Saint Luke’s Health System, Sanford Health, Sentara Healthcare, Texas Health Resources, TriHealth, UnityPoint Health, Virtua Health, and WellSpan Health.
Attachments
- Truveta enables the study of medical devices with detailed, de-identified clinical notes.
- Truveta enables the study of medical devices with minute-level precision from electronic health record details, admission-discharge-transfer data, and surgical procedure logs.
Ellie Lampton Truveta 2064092192 ellief@truveta.com
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