Medical Policy

This document addresses the use of  non-invasive heart failure and arrhythmia management and monitoring systems as an early indicator for heart failure decompensation and arrhythmia detection. Examples of non-invasive heart failure and arrhythmia management and monitoring systems include the following:

• AVIVO^® Mobile Patient Management System
• Bodyport^™ Cardiac Scale
• µ-Cor^™ Heart Failure and Arrhythmia Management System (HFAMS)
• VitalConnect Platform/VitalPatch^®
• ZOE Fluid Status Monitor

Note: Please see the following related document for additional information:

• CG-MED-40 External Ambulatory Cardiac Monitors
• CG-MED-91 Remote Therapeutic and Physiologic Monitoring Services

Investigational and Not Medically Necessary:

The use of non-invasive heart failure and arrhythmia management and monitoring systems, are considered investigational and not medically necessary for all indications.

AVIVO^® Mobile Patient Management System

On January 4, 2012, U.S. Food and Drug Administration (FDA) granted Medtronic Inc. (Mounds View, MN) FDA clearance through the 510(K) approval process for the AVIVO^® Mobile Patient Management System. The AVIVO System is a wearable, wireless arrhythmia detection system that is used to identify suspected cardiac arrhythmias and monitor physiologic signals. In combination with interpretation services provided by the Corventis Monitoring Center, as well as online review of data for prescribing physicians, AVIVO enables arrhythmia detection and other physiological data monitoring for up to 7 days. AVIVO monitors, derives, and displays, electrocardiogram (ECG), heart rate (including HR variability), activity, posture, respiration rate (including RR variability), and body fluid status.

The AVIVO system components include:

• PiiX1 (Adherent Device)- a worn device which is applied to the individual’s torso. It contains the ECG electrodes for recording ECG, heart rate and other physiological data.
• zLink^® (Gateway)- hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
• Server- receives sensor data from the PiiX via zLink. ECG, heart rate and other physiological parameters are presented to cardiographic technicians, who prepare and deliver the data to prescribing physicians.

The AVIVO system is indicated for individuals:

• With fluid management problems
• Taking diuretic medication
• Living with heart failure (HF)
• Living with end-stage renal disease
• Suffering from recurrent dehydration who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (for example, atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmia’s and conduction disorders.

At this time, there is insufficient evidence available to assess how the AVIVO device impacts management or affects net health outcomes in individuals with HF. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.

ZOE Fluid Status Monitor

On November 13, 2012, the FDA granted Noninvasive Medical Technologies, Inc. (NMT) (Las Vegas, NV), FDA clearance through the 510(K) approval process for the ZOE Fluid Status Monitor. Subsequently on January 22, 2014, the FDA approved the ZOE3 model as substantially equivalent to the predicate device. The ZOE3 is a non-invasive, battery powered impedance monitor designed as an early warning monitor for detecting changes in the fluid status of individuals with fluid management problems. The ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance.

The ZOE3 device is intended for use under the direction of a physician, for the non-invasive monitoring and management of individuals with fluid management problems including:

• Taking diuretic medication
• Living with HF
• Living with End-stage Renal Disease
• Recovering from Coronary Artery Disease related event
• Suffering from Recurrent Dehydration

 At this time, there is insufficient evidence available to assess how the ZOE3 device impacts management or affects net health outcomes in individuals with HF. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.

µ-Cor^™ Heart Failure and Arrhythmia Management System (HFAMS)

On June 10, 2019, the FDA granted ZOLL^® Medical Corporation (Pittsburg, PA), an Asahi Kasei Group Company that manufactures medical devices and related solutions, FDA clearance through the 510(K) approval process for their µ-Cor^™ Heart Failure and Arrhythmia Management System (HFAMS). The patch-based sensor can be worn continuously up to 30 days; the wireless system employs novel radiofrequency technology to monitor pulmonary fluid levels which is an early indicator for HF decompensation.

The µ-Cor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit  a “Thoracic Fluid Index”, it also  continuously records,  stores, and periodically transmits ECG, heart rate, respiration rate, activity and posture, The data provided can then be used to aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends.

The µ-Cor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for individuals who are 21 years of age or older:

1. Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or
2. Requiring fluid management (Product Label Information, 2019).

The FDA clearance of the device was based on an evaluation of data collected from the unpublished Measuring Thoracic Impedance in Hemodialysis Patients with the µ-Cor Monitoring System (MaTcH; NCT03072732) study, a prospective, non-significant risk, randomized, 2-arm premarket validation trial. The study enrolled 20 hemodialysis participants wearing the µCor 3.0 Heart Failure and Arrhythmia Management System; all participants also had the ZOE Fluid Status Monitor applied. During dialysis sessions, readings from both devices were recorded simultaneously. The results were summarized as follows: “the µ-Cor 3.0 mean correlation 0.95; ZOE mean correlation 0.211; µ-Cor 3.0 95% confidence interval (CI) [0.92, 0.99].” The Vital Signs Validation Study of the µ-Cor System (ViVUS, NCT02975050) was another prospective, non-significant risk, non-randomized, premarket study used to validate the capability of the µ-Cor 3.0 HFAMS to monitor ECG, HR, RR, posture and activity. This study enrolled 15 healthy volunteers performing activities of breathing, walking and resting. During these activities the participants’ RR, ECG, HR, activity and posture were collected for comparison. “Test results confirm that the µ-Cor Heart Failure and Arrhythmia Management System is at least as safe and effective as the predicate devices; therefore, the µ-Cor Heart Failure and Arrhythmia Management System is substantially equivalent to its predicate devices.” (Product Label Information, 2019).

There are additional ongoing clinical trials for the µ-Cor^™ Heart Failure and Arrhythmia Management System (NCT03476187, NCT04512703).

The current evidence base is insufficient to support µ-Cor^™ Heart Failure and Arrhythmia Management System (HFAMS) as an early indicator for HF decompensation and arrhythmia detection. Current completed studies, based on unpublished data, intend to validate the capabilities of the system. No evidence is available to assess how the device changes management or affects net health outcomes in the individuals with cardiac disease, as intended by FDA 510(k) clearance indications. Studies include relatively small sample sizes (limiting  generalizability) and short follow-up duration; therefore, the long-term complications are unknown. Adequately designed studies of sufficient duration, enrolling participants with established cardiac diseases are needed to confirm longer-term effects of HFAMS on whether health outcomes are significantly improved relative to standard of care for HF management.

VitalConnect Platform/VitalPatch^®

On February 6, 2020 the FDA granted 510K clearance to the VitalConnect Platform, a wireless remote monitoring system used by healthcare professionals for continuous collection of physiological data in home and healthcare settings. The device is indicated for use on general care patients who are 18 years of age or older as an aid to diagnosis and treatment. Data is measured via the VitalPatch^® RTM biosensor, a battery-operated adhesive patch with integrated sensors and a wireless transceiver that measures vital signs, including HR, ECG, HR variability, RR, RR interval, body temperature, skin temperature, step count, and posture. The VitalPatch provides arrhythmia detection and event notification, using a cloud-based algorithm it continuously analyzes ECG stream, technicians confirm results and provide notifications as needed. The patch was cleared by the FDA in 2019 (K190916).

The published literature demonstrating the efficacy of VitalPatch is limited. Clinical trial NCT03507439-REALIsM-HF Pilot Study (REALIsM-HF) was a non-randomized, multicenter, 12 week observational, prospective study in 3 countries from 2018-2021 with 29 participants. The study measured daily physical activity in participants aged ≥45 years with an established diagnosis of HF with NYHA class II–IV symptoms who were hospitalized due to worsening symptoms in the past 72 hours for the initiation of therapy. The AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor were used to collect data. HF with preserved ejection fraction was defined as EF ≥ 45% or reduced EF defined as EF ≤ 35%. However, due to non-compatibility of systems the data could not be derived from the VitalPatch biosensor at the time of report and no evaluation was possible. Additionally, activity data of the AVIVO patch as well as of the VitalPatch biosensor were not found to be scientifically evaluable.

At this time, there is insufficient evidence available to assess how the VitalPatch sensor impacts management or affects net health outcomes in individuals with HF. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.

Bodyport^™ Cardiac Scale

On July 29, 2022, the FDA granted 510(k) clearance to the Bodyport^™ Cardiac Scale (Bodyport Inc., San Francisco, CA), which is a battery powered non-invasive cardiovascular monitor and “smart” scale. This prescription device is intended for use in the home or clinic setting under the direction of a physician for the non-invasive monitoring and management of individuals with fluid management-related health conditions, including HF. The Bodyport is reported to measure and track body weight, peripheral impedance, pulse rate, and center of pressure in people over 21 years of age who are able to stand on the device platform and weigh less than 180 kg (397 lbs.). The device provides a ‘Bodyport Fluid Index’ a measure of biomarkers that is purported to augment weight and symptom tracking with longitudinal data regarding an individual’s heart function and fluid status. Lower body peripheral impedance, pulse rate, and center of pressure are measured through the feet of the user when standing on a platform with bare feet. The data is displayed on the device screen and then automatically transmitted to the Bodyport cloud app where it can be accessed through a supported web-based browser, dashboard, or application programming interface (API).

The published literature demonstrating the efficacy of Bodyport is limited. The three studies identified were industry sponsored. Yazdi and colleagues (2021) assessed the accuracy of the scale’s ability to capture ballistocardiography, electrocardiography, and impedance plethysmography signals in individuals’ feet while standing on the scale platform; the data was used to measure stroke volume and cardiac output compared with the gold-standard direct Fick method. Thirty-two (n=32) individuals with unexplained dyspnea undergoing an invasive cardiopulmonary exercise test were analyzed. The results demonstrated that the Bodyport scale obtained, and the direct Fick measurements of stroke volume and cardiac output before and immediately after invasive cardiopulmonary exercise tests, correlated with r=0.81 and r=0.85 respectively (p<0.001 each). The mean error of the scale-estimated stroke volume was −1.58 mL, the mean error for the scale-estimated cardiac output was −0.31 L/min, both had a 95% limit of agreement. The changes in stroke volume and cardiac output before and after exercise were 78.9% and 96.7% concordant, respectively. This study did not provide any data addressing the clinical utility of the device, including any potential health outcomes benefit for its use.

A randomized trial by Victoria-Castro and colleagues (2022) assessed the impact of digital health technologies on the Kansas City Cardiology Questionnaire (KCCQ) quality of life rating in 200 individuals with HF. The trial compared usual care for HF to three digital technologies designed to promote self-management. Bodyport was one of the three digital interventions used to provide this data. However, the results provided by the authors were not stratified by intervention type. Thus, the individual contributions or impact of the Bodyport scale on the outcomes is unclear from this data. Additionally, the authors acknowledged that due to the exclusion of individuals over 80 years old, the study may be intrinsically biased towards individuals with more digital literacy.

Fudim and colleagues (2023) completed a prospective, multicenter study of 300 individuals that evaluated the accuracy of the Bodyport cardiac scale in predicting 50 worsening HF events through its composite heart function index score. The index is a composite measure including hemodynamic factors including weight, peripheral impedance, pulse rate and variability, and estimates of stroke volume, cardiac output, and blood pressure. The accuracy of the index in predicting worsening HF events was compared with simple weight-based algorithms (for example, weight increase of 3 lbs. in 1 day or 5 lbs. in 7 days). The authors concluded that the device is able to assess biomarkers related to cardiac congestion and perfusion, and showed a high correlation with the Fick method for measuring cardiac output (r=0.85, [p<0.001]), and stroke volume (r=0.81, [p<0.001]), and that future studies are needed to determine the ability of the index to improve clinical outcomes.

There are additional ongoing clinical trials for the Bodyport device (NCT04975633, NCT04882449, NCT04394754).

At this time, there is insufficient evidence available to assess how the Bodyport device impacts management or affects net health outcomes in individuals with HF, as intended by FDA 510(k) clearance indications. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.

Recommendations and Guidelines

The 2022 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) guideline for the management of heart failure, which replaces the 2017 ACC/AHA/HFSA Focused update of the 2013 American College of Cardiology Foundation (ACCF)/AHA Guideline for the Management of Heart Failure, does not address the use of non-invasive wireless technology to monitor pulmonary fluid levels as an early indicator for HF decompensation or arrhythmia detection (Heidenreich, 2022).

According to the Centers for Disease Control (CDC) and Prevention, nearly 6.2 million Americans are currently diagnosed with HF, and more than 960,000 new cases are diagnosed each year (CDC, 2020). Approximately 50% of individuals with HF die within 5 years of diagnosis. As a result of HF, the weakened heart muscle causes inadequate filling of the left ventricle, as well as a backflow of blood into the left atrium, both resulting in decreased cardiac output and increased symptoms for the afflicted individual. Symptoms can include shortness of breath, fatigue, and swelling in the ankles, feet, legs, abdomen and veins in the neck. Currently there is no cure for HF; medical therapy includes a combination of diuretics, digoxin, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), beta-blockers, and aldosterone antagonists. Some individuals may remain symptomatic despite medical therapy. Ongoing studies evaluate other treatment options to assist physicians in the management of individuals with severe HF.

Arrhythmias are deviations from the normal cadence of the heartbeat, which cause the heart to pump improperly. More than four million Americans have arrhythmias, most of which pose no significant health threat. As people age, the probability of experiencing an arrhythmia increases. In the United States, arrhythmias are the primary cause of sudden cardiac death, accounting for more than 350,000 deaths each year. The standard initial measure for a diagnosis of arrhythmias involves the use of electrocardiogram (EKG) testing, which allows evaluation of the electrical function of the heart.

510k Clearance: The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. The FDA does not “approve” 510(k) submissions. It “clears” them.

Arrhythmia: Abnormal heart rhythms which may be classified as either atrial or ventricular, depending on the origin in the heart. Individuals with arrhythmias may experience a wide variety of symptoms ranging from palpitations to fainting.

Guideline-directed medical therapy (GDMT): The term replaces and is synonymous with “Optimal medical therapy.”

Heart failure: A condition in which the heart no longer adequately functions as a pump. As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the lungs and other organs.

New York Heart Association (NYHA) Definitions: The NYHA classification of HF is a 4-tier system that categorizes subjects based on subjective impression of the degree of functional compromise; the four NYHA functional classes are as follows:

• Class I - individuals with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; symptoms only occur on severe exertion.
• Class II - individuals with cardiac disease resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity (for example, moderate physical exertion such as carrying shopping bags up several flights of stairs) results in fatigue, palpitation, dyspnea, or anginal pain.
• Class III - individuals with cardiac disease resulting in marked limitation of physical activity; they are comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
• Class IV - individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort; symptoms of HF or the anginal syndrome may be present even at rest; if any physical activity is undertaken, discomfort is increased.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure, Nat Rev Cardiol. 2011; 8(1):30-41.
2. Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012; 126(4):501-506.
3. Fudim M, Yazdi D, Egolum U, et al. Use of a cardiac scale to predict heart failure events: Design of SCALE-HF 1. Circ Heart Fail. 2023; 16(5):e010012.
4. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association, Circ Heart Fail. 2013; 6(3):606-619.
5. Victoria-Castro AM, Martin M, Yamamoto Y, et al. Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation. Clin Cardiol. 2022; 45(8):839-849.
6. Yazdi D, Sridaran S, Smith S, et al. Noninvasive scale measurement of stroke volume and cardiac output compared with the direct Fick method: a feasibility study. J Am Heart Assoc. 2021; 10(24):e021893.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bayer, Inc. Northwestern University Feinberg School of Medicine. REALIsM-HF Pilot Study (REALIsM-HF). NLM Identifier: NCT03507439. Last updated July 3, 2023. Available at:  https://clinicaltrials.gov/study/NCT03507439?term=NCT03507439&rank=1.  Accessed on May 23, 2024.
2. Devore, A. Duke Clinical Research Institute. Surveillance and alert-based multiparameter monitoring to reduce worsening heart failure events (SCALE-HF 1). NLM Identifier: NCT04882449. Last updated July 20, 2022. Available at: https://clinicaltrials.gov/study/ NCT04882449. Accessed on May 9, 2024.
3. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022. 145:e895-e1032.
4. January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019. pii: S0735-1097(19)30209-8.
5. Kyma Medical Technologies. Vital Signs Validation study of the u-Cor System (ViVUS Validation) (ViVUS). NLM Identifier: NCT02975050. Last updated July 7, 2020. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02975050?term=NCT02975050&draw=2&rank=1. Accessed on May 9, , 2024.
6. Kyma Medical Technologies. External Measure of Thoracic Fluid and Vital Signs (Ease). NLM Identifier: NCT02369042. Last updated July 19, 2017. Available at: https://clinicaltrials.gov/study/NCT02369042?cond=heart%20failure&intr=uCor&rank=2. Accessed on May 9, 2024.
7. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012; 60(14):1297-1313.
8. U.S. Food and Drug Administration (FDA). Medical Devices. Bodyport™ Cardiac Scale- No. K211585. Rockville, MD: FDA. July 29, 2022. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211585.pdf. Accessed on May 9, 2024.
9. U.S. Food and Drug Administration (FDA). Medical Devices. µ-Cor Heart Failure and Arrhythmia Management System – No. K172510. Rockville, MD: FDA. May 11, 2018. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172510. Accessed on May 9, 2024.
10. U.S. Food and Drug Administration (FDA). Medical Devices. VitalConnect- No. K192757. Rockville, MD: FDA. February 6, 2020. Available at: K192757.pdf (fda.gov). Accessed on May 22, 2024.
11. U.S. Food and Drug Administration (FDA). Medical Devices. VitalPatch-No. K190916. Rockville, MD: FDA. April 9, 2019. Available at: K190916.pdf (fda.gov). Accessed on May 22, 2024.  
12. U.S. Food and Drug Administration (FDA). Medical Devices. ZOE Fluid Status Monitor Model ZOE3- No. K133301. Rockville, MD: FDA. January 22, 2014. Available at: K133301.pdf (fda.gov), Accessed on May 9, 2024.
13. Yale University. Evaluating efficacy of digital health technology in the treatment of congestive heart failure. NLM Identifier: NCT04394754 Last updated on May 18, 2023. Available at: https://clinicaltrials.gov/study/NCT04394754. Accessed on May 9, 2024.
14. Yazdi D. USC and Bodyport remote heart failure management study. NLM Identifier: NCT04975633. Estimated completion date December 31, 2023. Available at: https://clinicaltrials.gov/study/NCT04975633. Accessed on May 9, 2024.
15. Zoll Medical Corporation. Benefits of Microcor in ambulatory decompensated heart failure (BMAD-TX). NLM Identifier: NCT04096040. Last updated May 6, 2022. Available at: https://www.clinicaltrials.gov/ct2/show/NCT04096040?term=%C2%B5Cor&cond=Heart+Failure&draw=2&rank=2. Accessed on May 9, 2024.
16. Zoll Medical Corporation. Benefits of µCor in Ambulatory Decompensated Heart Failure (BMADHF). NLM Identifier NCT03476187. Last updated May 3, 2022. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03476187?term=%C2%B5Cor&cond=Heart+Failure&draw=2&rank=1. Accessed on May 9, 2024.
17. Zoll Medical Corporation. Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH). Identifier: NCT04512703. Last updated June 3, 2021. Accessed on May 9, 2024. Available at: https://clinicaltrials.gov/study/NCT04512703?cond=heart%20failure&term=%C2%B5Cor&aggFilters=status:not%20rec%20act%20com&rank=2&tab=results.
18. Zoll Medical Corporation. Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System (MaTcH). NLM Identifier: NCT03072732. Last updated November 4, 2020. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03072732?term=NCT03072732&draw=2&rank=1. Accessed on May 9, 2024.

1. Centers for Disease Control and Prevention. Heart failure. Last reviewed January 5, 2023. Available at: https://www.cdc.gov/heartdisease/heart_failure.htm. Accessed on May 9, 2024.
2. National Heart, Lung and Blood Institute. Heart failure. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Hf/HF_WhatIs.html. Last updated on March 24, 2022. Accessed on May 9, 2024.

Arrhythmia Detection
AVIVO^® Mobile Patient Management System
Bodyport^™ Cardiac Scale
Heart Failure Decompensation
Non-invasive Heart Failure and Arrhythmia Management and Monitoring System
µ-Cor^™ Heart Failure and Arrhythmia Management System (HFAMS)
VitalConnect Platform/VitalPatch^® biosensor
ZOE Fluid Status Monitor

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.