Regulatory Update: Moni-Patc Intraoperative Temperature Patch Validation Against Esophageal and Bladder Reference Temperatures

By Dr. Hatem Rabeh · Published April 24, 2026 · Updated April 3, 2026

Publication date context February 20 2026. Regulatory update on the Moni-Patc intraoperative temperature patch reports a clinical accuracy validation against esophageal and bladder temperatures. The study is not yet recruiting and is led by Murata Vios, Inc. and the University of Minnesota. The record describes a device driven evaluation in an operating room environment under intraoperative conditions and aligns with ongoing efforts to verify safety and performance of a skin mounted temperature monitor.

What changed in the record and why it matters?

The ClinicalTrials.gov record NCT07397065 identifies the Moni-Patc Temperature Monitoring Patch System as the intervention under study in an intraoperative setting. While the sponsor names Murata Vios, Inc. and the University of Minnesota, the entry notes the trial status as not yet recruiting. This signals early stage evaluation focused on locating and describing the device in a surgical workflow rather than reporting final results. Stakeholders such as hospital clinical teams, quality and regulatory professionals, and device developers should monitor updates for potential implications to clinical practice and future regulatory submissions.

What is the study design and setting?

The study centers on a patch based temperature monitoring system used during surgery. Investigators will compare patch measurements with reference temperatures taken from esophageal and bladder routes. The aim is to establish accuracy and determine whether the patch can reliably reflect core temperature in a perioperative context. The information provided in the record emphasizes device level assessment rather than marketing claims at this stage.

What are the reference standards and endpoints?

Esophageal and bladder temperatures are cited as reference standards for comparison with the Moni-Patc patch readings. The primary objective is accuracy validation against these reference sources. The documentation does not present numerical endpoints in the accessible record, but standard practice would consider bias, precision and trending performance as part of a complete evaluation. The absence of published results at this time means conclusions about performance remain pending regulatory review and clinical validation.

What are the regulatory implications for this device?

Given the focus on intraoperative temperature monitoring and the involvement of a commercial sponsor, findings from this study could inform future regulatory submissions and post market expectations. The record helps clarify the intended purpose and the performance questions being addressed. Regulators would expect transparent reporting of methods and results, including any limitations identified in comparative temperature assessment and how measurement differences will be interpreted in a clinical context.

What safety and performance considerations are being addressed?

Safety is addressed through real world clinical use in a surgical setting, where sensor contact and monitoring stability come into play. Performance considerations include the patchs ability to track temperature in a manner consistent with core references. The current documentation frames safety and performance as ongoing evaluation rather than final claims, aligning with MDR style requirements to distinguish intended use from confirmatory marketing statements.

How will data be reported and shared?

The record on ClinicalTrials.gov serves as the public record for this validation effort. While the entry confirms not yet recruiting status, updates and eventual results would typically be released on the same platform and documented with study outcomes, limitations and sponsor commentary. Stakeholders should verify the record for the most current information and planned dissemination routes. The link to the public registry is provided below for reference. The reference link is https://clinicaltrials.gov/study/NCT07397065?term=medical+device.

What does this mean for clinicians and developers?

The validation effort demonstrates a focused approach to establishing device reliability in a challenging clinical environment. If future results support concordance with esophageal and bladder temperatures, the patch could provide a convenient alternative for intraoperative monitoring. Regulators will likely scrutinize the methodology and reporting transparency as part of the path toward safety certification and permissible use in surgical settings.