United States Patient Fluid Status Monitor Device Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Global Fluid Status Monitor Device Market is estimated at a CAGR of 8.32% during the forecast period (2024-2031).

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Key Development:

United States: Recent Patient Fluid Status Monitor Device Updates

✅ In October 2025, Mode Sensors' Re:Balans hydration monitoring system received FDA 510(k) clearance as a non-invasive wearable device for continuous monitoring of patient fluid status, supporting clinical decisions related to dehydration and fluid overload.

✅ In September 2025, FluidAI Medical's Origin device received FDA 510(k) clearance for real-time bedside monitoring of surgical effluent using standard drains, helping clinicians assess post-operative fluid status and detect complications earlier.

✅ In October 2025, regulatory documentation clarified the clinical indications of wearable fluid-monitoring devices, reinforcing their role in physician-directed monitoring of hydration balance and fluid management in hospital settings.

✅ In Late 2025, new CMS reimbursement pathways were introduced for remote physiologic monitoring of fluid status, improving commercial viability and accelerating adoption of continuous fluid-monitoring technologies across care settings.

Europe: Recent Patient Fluid Status Monitor Device Updates

✅ In October 2025, Mode Sensors announced progress toward EU medical device clearance for its Re:Balans wearable, positioning the technology for entry into European healthcare markets in early 2026.

✅ In Late 2025, updates to the EU Medical Device Regulation (MDR) clarified certification pathways for novel fluid-status monitoring technologies, supporting faster approval timelines for innovative non-invasive devices.

✅ In Late 2025, European medical-device manufacturers advanced bioimpedance and thoracic-impedance-based fluid monitoring technologies, expanding clinical options for non-invasive volume assessment in critical and post-surgical care.

✅ In Late 2025, partnerships and distribution initiatives across Europe strengthened the deployment of next-generation fluid-monitoring systems, aligning with evolving regulatory requirements and growing clinical adoption.

Key Players:

=> Medtronic, Baxter, ImpediMed, Zynex Medical, Maltron, Serenno Medical, Deltex Medical Limited, and Sensible Medical Innovations LTD.

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Key Segments:

By Type

Non-Invasive - ~65% share, driven by patient comfort, ease of use, and reduced risk of complications.
Invasive - ~35% share, preferred in critical care settings for high-accuracy fluid assessment.

By Indication

Kidney Disease - ~45% share, rising prevalence of chronic kidney disorders fueling demand.
Dehydration - ~35% share, widely used in acute care and emergency settings.
Others - ~20% share, including postoperative monitoring and chronic disease management.

By End-User

Hospitals - ~70% share, major adoption due to advanced diagnostic infrastructure.
Ambulatory Surgical Centers - ~20% share, increasing use for outpatient procedures.
Others - ~10% share, including specialty clinics and homecare settings.

By Region

North America - ~38% Share
Strong healthcare infrastructure and early adoption of advanced monitoring technologies.

Europe - ~25% Share
Growing focus on preventive care and chronic disease management.

Asia Pacific - ~22% Share
Rapid growth due to increasing patient population and improving healthcare access.

Latin America - ~10% Share
Gradual expansion driven by modernization of healthcare facilities.

Middle East & Africa - ~5% Share
Emerging market with rising investments in healthcare infrastructure.

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FAQ

Q: What is the growth rate of the Fluid Status Monitor Device Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 8.32% during the forecast period from 2024 to 2031.

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