ModifiedUnitedHealthcarePolicy CSO82NMB

Neurophysiologic Testing and Monitoring (for New Mexico Only)

Policy governing coverage and medical necessity of neurophysiologic and electrodiagnostic testing (e.g., nerve conduction studies, EMG, QST, VEPs, physiologic wearables) for UnitedHealthcare members in New Mexico.

Policy Summary

PayerUnitedHealthcare

PolicyNeurophysiologic Testing and Monitoring (for New Mexico Only)

Policy CodePolicy CSO82NMB

Change TypeUpdated coverage examples and CPT list (material)

Effective DateApril 1, 2025

Next Review DateN/A

Key ActionVerify current applicable CPT codes and prior authorization requirements with the plan before ordering testing or devices.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale Removed list of examples of non-invasive automatic, portable, or automated point of care nerve conduction monitoring systems: NC-state System, Brevios NCS-Monitor, and Advance System

Applicable Codes Updated list of applicable CPT codes to reflect annual edits; removed 96003

Supporting Information Updated Clinical Evidence and References sections to reflect the most current information

Archived previous policy version CSO82NM.A

NM onlyState-specific

Multiple CPT/HCPCSApplicable codes

Several listedUnproven items

~0.91Wearable GTCS sensitivity

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Macro‑EMG / POC NCSWeak evidence areas

Coverage and Medical Necessity Criteria

Proven and medically necessary NCS/EMG indications

Covered when the following clinical situations apply:

Indications for proven and medically necessary nerve conduction studies: Peripheral neuropathy/polyneuropathy (e.g., inherited, metabolic, traumatic, entrapment syndromes); plexopathy; myopathy; neuromuscular junction disorders (e.g., myasthenia gravis); motor neuron disease; radiculopathy (cervical, thoracic, or lumbosacral); treatment guidance such as muscle localization for botulinum toxin injections when required to identify affected muscles; and nerve conduction studies with or without standard late responses (F‑wave, H‑reflex) when performed without needle EMG for individuals with lymphedema, individuals treated with anticoagulants, or individuals being evaluated for carpal tunnel syndrome.

From policy: proven and medically necessary list.

Indications and appropriateness

Electrodiagnostic testing (NCS + needle EMG) is indicated when AANEM criteria support testing:

EDX Indications per AANEM model policy: EDX testing is indicated for traumatic nerve lesions (diagnosis and prognosis); focal neuropathies/entrapment syndromes (eg, carpal tunnel, ulnar neuropathy) for localization; generalized neuropathies (diabetic, uremic, metabolic, toxic, hereditary, immune‑mediated); neuromuscular junction disorders; radiculopathy; myopathy; and plexopathy.

American Association of Neuromuscular and Electrodiagnostic Medicine model policy

When EDX should be seriously considered for distal symmetric polyneuropathy: When symptoms or physical findings are moderate to severe; standard neuropathy labs (eg, diabetes screening, vitamin B12, monoclonal gammopathy testing) do not indicate a likely etiology; atypical presentation (predominant motor symptoms, proximal deficits, or asymmetry); presence of signs suggesting another disorder (eg, radiculopathy); rapid progression; unknown duration or severity; exposure to neurotoxic agents or medications; family history suggesting hereditary neuropathy; or discrepancy between signs and symptoms.

AANEM Electrodiagnosis for Distal Symmetric Polyneuropathy guidance

Situations where EDX is likely low yield: EDX testing is likely low yield when findings are symmetric, distal, predominantly sensory; symptoms and findings are mild; there is a known cause (eg, diabetes mellitus) with little suspicion of a coexisting nerve disorder.

AANEM guidance

Coverage interpretation and criteria

Policy-level interpretive summary based on extracted evidence and guidelines

Wearable seizure-detection devices: Use of wearable seizure‑detection devices is recommended only when devices are clinically validated for generalized tonic‑clonic seizures (GTCS) and focal bilateral tonic‑clonic seizures (FBTCS) and when used in contexts with significant safety concerns (for example, unsupervised patients not sharing a bedroom where alarms permit rapid intervention, within approximately 5 minutes). Current ILAE‑IFCN guidance does not support clinical use of available wearables for other seizure types (weak/conditional recommendation).clinical validation for GTCS/FBTCS

ILAE‑IFCN working group statement (Beniczky 2021)

Wearable and smartphone monitoring for Parkinson disease: Published studies show feasibility and variable reliability/validity (eg, moderate‑to‑excellent test‑retest reliability for some smartphone features and modest correlations in some studies), but evidence is limited by small samples and lack of controlled trials demonstrating improved clinical outcomes; therefore devices may provide phenotypic data but clinical utility for improving outcomes remains unproven.evidence limited; further validation required

AAN/AANEM and device study summaries

Evidence summaries — device-specific

Evidence-based summaries and device status

sEMG for mechanical ventilation monitoring: Systematic reviews report that extra‑diaphragmatic sEMG may evaluate respiratory muscle loading/unloading and drive during mechanical ventilation, but the overall evidence is low quality (small studies, unclear bias) with insufficient diagnostic accuracy data to support routine clinical use; larger, well‑designed studies are needed.

AbuNurah et al. systematic review (7 studies)

Wearable sEMG for seizure detection: Wearable sEMG devices can detect generalized tonic‑clonic seizures; a multicenter trial (Halford et al.) in 199 patients reported 76% overall detection, 100% detection when placed over mid‑biceps, but with high false alarm rates and skin irritation adverse events; at least one device (SPEAC System) has FDA de novo clearance for adjunctive monitoring.

Halford et al. multicenter phase III trial; FDA de novo clearance for SPEAC System

Surface EMG in neuromuscular disorders: AANEM concludes data are insufficient to determine clinical utility of sEMG for distinguishing neuropathic from myopathic conditions and for many specific neuromuscular diagnoses; some techniques show promise but require further validation in larger cohorts.

The policy lists several technologies as unproven and not medically necessary when used as substitutes for standard electrodiagnostic testing. Specifically, non‑invasive automatic/portable point‑of‑care nerve conduction monitoring systems that test only distal motor latencies and conduction velocities are identified as unproven for electrodiagnostic purposes. Macro‑EMG and multiple surface‑based techniques (including SEMG and wearable physiologic monitoring for seizure or movement disorders) are likewise listed among tests lacking sufficient evidence for routine clinical use.

Macro‑EMG and point‑of‑care/portable NCS devices have been evaluated in small studies and case series but the literature is currently limited and methodologically heterogeneous. The policy notes weak evidence for these modalities and states that further studies with robust patient‑relevant outcomes are required before they can be considered standard of care; until then they are regarded as experimental or adjunctive.

Wearable devices for seizure detection and movement monitoring are addressed with attention to clinical validation and intended seizure types. The ILAE‑IFCN working group does not recommend current wearable devices for seizure types other than generalized tonic‑clonic seizures (GTCS) and focal bilateral tonic‑clonic seizures (FBTCS), and recommends using only clinically validated devices for GTCS/FBTCS in high‑safety scenarios (for example, unsupervised patients where alarms permit rapid intervention). In general, non‑validated wearables for other seizure types or monitoring purposes are not supported by current guidance and the policy treats those as outside recommended clinical use.

Evidence for sEMG is limited in several important clinical contexts. Systematic reviews and practice statements highlight that studies of extra‑diaphragmatic sEMG during mechanical ventilation excluded patients with neuromuscular disorders, those receiving neuromuscular blocking agents, and some other populations; as a result, the policy cautions against broad application of sEMG in those groups. Additionally, AANEM guidance indicates insufficient data to support sEMG as a reliable standalone diagnostic tool across many neuromuscular disorders.

The policy previously listed specific examples of non‑invasive automatic, portable, or automated point‑of‑care nerve conduction monitoring systems but notes an operational change effective 04/01/2025: the examples were removed from the Coverage Rationale. Providers should not rely on the removed examples as an endorsement of clinical use.

Consistent with the exclusions, the policy explicitly states that the listed devices and tests (see exclusions) are considered unproven and not medically necessary because evidence demonstrating clinical efficacy and patient‑relevant outcomes is insufficient. Claims for these technologies may be denied on that basis.

At the policy level, the use of macro‑EMG, point‑of‑care NCS devices, and many physiologic wearable seizure/movement recording technologies is characterized as having limited evidence. The document indicates these technologies may be useful in exploratory or adjunctive roles but emphasizes that current data do not demonstrate consistent improvements in patient outcomes, so routine clinical adoption is not supported.

Quantitative Sensory Testing (QST) can document sensory threshold changes and has some evidence supporting longitudinal assessment in conditions like diabetic neuropathy, but overall findings are inconsistent. Systematic reviews report mixed results for QST as a predictor of postoperative pain or broad prognostic use; therefore, routine use of QST for generalized prognostication or postoperative pain prediction is not recommended without further validating studies and reproducible protocols.

Surface EMG (sEMG) currently lacks sufficient high‑quality evidence to reliably distinguish neuropathic from myopathic conditions or to serve as a standalone diagnostic test for many neuromuscular disorders. Professional guidance (AANEM) and systematic reviews conclude that sEMG methods are heterogeneous and that additional standardized research is needed before sEMG can be routinely used for diagnostic classification.

Applicable Codes and Coding Details

Selected QST / novel codesCPT

0106T	Quantitative sensory testing (QST), testing and interpretation per extremity; using touch pressure stimuli to assess large diameter sensation.
0107T	Quantitative sensory (QST); testing and interpretation per extremity; using vibration stimuli to assess large diameter fiber sensation testing.
0108T	Quantitative sensory testing (QST), testing and interpretation per extremity; using cooling stimuli to assess small nerve fiber sensation and hyperalgesia.
0109T	Quantitative sensory testing (QST) , testing and interpretation per extremity; using heat-pain stimuli to assess small nerve fiber sensation and hyperalgesia.
0110T	Quantitative sensory testing (QST), testing and interpretation per extremity; using other stimuli to assess sensation.
0464T	Visual evoked potential, testing for glaucoma, with interpretation and report.
0778T	Surface mechanomyography (sMMG) with concurrent application of inertial measurement unit (IMU) sensors for measurement of multi-joint range of motion, posture, gait, and muscle function.

EMG / NCS / related CPT codesCPT

95860	Needle electromyography; 1 extremity with or without related paraspinal areas.
95861	Needle electromyography; 2 extremities with or without related paraspinal areas.
95863	Needle electromyography; 3 extremities with or without related paraspinal areas.
95864	Needle electromyography; 4 extremities with or without related paraspinal areas.
95865	Needle electromyography; larynx.
95866	Needle electromyography; hemidiaphragm.
95867	Needle electromyography; cranial nerve supplied muscle(s) , unilateral.
95868	Needle electromyography; cranial nerve supplied muscles, bilateral.
95869	Needle electromyography; thoracic paraspinal muscles (excluding T1 or T12).
95870	Needle electromyography; limited study of muscles in extremity or non-limb (axial) muscles (unilateral or bilateral), other than thoracic paraspinal, cranial nerve supplied muscles, or sphincters.

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HCPCS / miscellaneous codesHCPCS

A9279	Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified.
A9280	Alert or alarm device, not otherwise classified.
G0255	Current perception threshold/sensory nerve conduction test (SNCT), per limb, any nerve.
S3900	Surface electromyography (EMG).

Covered CPT CodesCPT

No codes listed

FDA Product Codes / Device Classificationmixed

LLN	Product code for current perception threshold and sensory nerve conduction threshold testing
GXB	Product code 'esthesiometer' / quantitative sensory testing
LQW	Product code referenced for sensory devices
GWI	Product code '2-point discriminator' / vibration threshold measurement
JXE	Product code for point of care nerve conduction devices (NCS-Monitor, Advance System)

Applicable CPT code changesCPT

96003

CPT removed from applicable codes per Summary of Changes (removed 96003)

PKG wear time — typical wear time for PKG device

Typical PKG wear time6 to 10 days

Primary purposeContinuous, objective, ambulatory assessment of Parkinson disease symptoms (tremor, bradykinesia, dyskinesia)

Device form factorWrist-worn movement recording device

FDA statusReceived FDA 510(k) clearance (August 22, 2014)

Prior Authorization, Documentation, and Provider Responsibilities

Note

Applicable codes (reference only)

The following list of procedure and diagnosis codes is provided for reference only. Inclusion does not imply coverage or guarantee payment. Providers should verify member-specific benefit terms and current coding/prior authorization requirements with the payer before billing.

Example referenced CPT and HCPCS codes include (not all-inclusive): 0106T, 0107T, 0108T, 0109T, 0110T, 0464T, 0778T, 95860-95870 series and related EMG/NCS CPTs. Verify current CPT descriptors and updates effective 04/01/2025.
Listing of a code in this policy does not determine coverage; federal, state, or contractual benefit terms and applicable laws govern.

Prior Authorization

Prior authorization: supervision and indication

Electrodiagnostic testing (NCS and needle EMG) should be performed with appropriate equipment, by qualified personnel, and with physician supervision per specialty society guidance. Direct or immediate availability of the supervising EDX physician is required when technologists perform delegated components.

Terms and Device Definitions

Electrodiagnostic testing (nerve conduction studies and electromyography) assesses peripheral nerve conduction and muscle electrical activity and is intended to complement history and physical examination when motor or sensory deficits require further workup. Needle EMG and NCS are commonly performed together as part of a complete electrodiagnostic evaluation; late response testing (F‑wave, H‑reflex) may be included when appropriate. These studies are used to evaluate conditions such as peripheral neuropathy, radiculopathy, neuromuscular junction disorders, myopathy, plexopathy, and for guidance in procedures such as muscle localization for botulinum toxin injections.

Nerve conduction studies (NCS)

DefinitionTests assessing conduction velocity, latency, amplitude and shape of peripheral nerve responses

Common componentsMotor and sensory nerve conduction studies; may include late responses (F‑wave, H‑reflex)

Typical useAssess peripheral neuropathy, entrapment syndromes, radiculopathy and complement needle EMG

Performance standardsPerformed with equipment providing full waveform assessment; done by physician or trained technician under direct physician supervision

Clinical Background and Evidence Summary

In clinical practice, NCS measure conduction velocity, latency, amplitude and waveform of peripheral nerve responses and are typically interpreted together with needle EMG to clarify the localization and nature of neuromuscular disorders. Appropriate selection of tests should be driven by the clinical differential diagnosis derived from history and examination, and testing should be performed under appropriate physician supervision per professional society recommendations.

Policy Changes and Revision History

2025-04-01CPT code updateLatest

Applicable CPT codes were updated to reflect annual edits; CPT 96003 was removed from the applicable codes list.

2025-04-01Coverage rationale revision

Operational update removed example devices from the Coverage Rationale (NC-state System, Brevios NCS-Monitor, Advance System).

2025-04-01Document archival/administrative

Policy Summary

PayerUnitedHealthcare

PolicyNeurophysiologic Testing and Monitoring (for New Mexico Only)

Policy CodePolicy CSO82NMB

Change TypeUpdated coverage examples and CPT list (material)

Effective DateApril 1, 2025

Next Review DateN/A

Key ActionVerify current applicable CPT codes and prior authorization requirements with the plan before ordering testing or devices.

SourceLink

On This Page

Quantitative Sensory Testing (QST): QST can document sensory threshold changes and may be useful in longitudinal assessment of diabetic neuropathy (Level B AAN), but results are methodology‑dependent, reproducibility varies, and QST should not be used as the sole diagnostic method; instruments and protocols must be validated and reproducible for clinical use.validated instrument and reproducible protocol

AAN and AANEM guidance on QST limitations

Surface EMG (SEMG): Current evidence for surface EMG and SEMG‑based seizure monitoring is weak and heterogeneous; while SEMG may have research or narrow monitoring applications (eg, certain ALS outcome measures or respiratory muscle research), standardized methods and diagnostic accuracy sufficient for broad clinical use are lacking and further high‑quality studies are needed.insufficient diagnostic accuracy evidence

AANEM practice topic and systematic review conclusions

AANEM practice topic level U/C evidence

Visual evoked potentials and other novel devices: Certain devices and quantitative systems (eg, icVEP for glaucoma, PKG, Kinesia) have been evaluated in small studies or hold FDA clearances for specific adjunctive uses, but overall evidence for broad clinical impact on outcomes is limited and variable; additional high‑quality studies are required.

Device summaries and small study limitations

Use test equipment that assesses all parameters of recorded signals; screening-only devices are unacceptable for diagnostic NCS.

One attending physician should supervise and perform or directly oversee all components; reporting NCS and EMG in separate reports is generally inappropriate.

Physician must be available to reassess testing if unexpected results arise; patient should remain until review of results by supervising physician when appropriate.

Prior Authorization

Seizure wearable validation and safety

Use of clinically validated wearable devices is supported only for automated detection of generalized tonic-clonic seizures (GTCS) and focal bilateral tonic-clonic seizures (FBTCS) where safety concerns exist (e.g., unsupervised patients not sharing a bedroom). Use for other seizure types is not currently recommended.

Only FDA-cleared or clinically validated devices for GTCS/FBTCS (for example: devices cleared as adjunctive seizure monitors) should be used for automated detection.
When used, devices should enable rapid caregiver notification (ideally within ~5 minutes) and be part of an overall safety plan.
Devices that are not validated for seizure types other than GTCS/FBTCS are not recommended for clinical decision-making.

Denial Risk

Denial triggers: unproven tests

Claims for non-invasive automatic, portable, or point-of-care nerve conduction monitoring systems that only test distal motor latencies and conduction velocities, and other unproven tests listed in this policy, may be denied as not medically necessary.

Examples of unproven/unacceptable: non‑invasive automatic portable NCS devices that test only distal motor latencies and conduction velocities; macro-EMG; SEMG-based seizure monitoring when not clinically validated for intended seizure type; surface mechanomyography (sMMG); certain QST modalities without reproducible methodology.
Providers should ensure submitted documentation justifies medical necessity and aligns with benefit terms to avoid denial.

Denial Risk

Device validation impacts acceptability

Device-level validation impacts whether use is acceptable for clinical monitoring. FDA de novo clearance or other clinical validation supporting device performance for the intended seizure type increases acceptability; non-validated devices or those validated only for different indications may not be appropriate for clinical use.

Confirm device model, FDA status/clearance, intended indication, and supporting validation data when documenting use.
Devices validated only for GTCS/FBTCS should not be generalized to other seizure types without evidence.
Claims referencing devices or CPT examples removed from Coverage Rationale (see policy changes effective 04/01/2025) may be subject to review or denial.

Denial Risk

sEMG for MV monitoring — evidence limitations

Evidence supporting surface EMG (sEMG) for monitoring respiratory mechanics in mechanically ventilated patients is limited and of low quality; diagnostic accuracy across broad MV populations is not established.

Current literature demonstrates possible utility of extra-diaphragmatic sEMG for assessing respiratory muscle loading/unloading and drive, but studies have small sample sizes and high/unclear risk of bias.
Do not use sEMG for MV monitoring as a sole determinant of management decisions without corroborating clinical data and validated reference standards.
Document limitations of evidence when requesting authorization and provide rationale for clinical utility in the specific patient.

Documentation Required

Supervision and documentation

Clinical and electrophysiologic data collection must be under the supervision of an EDX physician; physicians performing EDX should have documented training/experience (neurology or PM&R residency/fellowship, board certification, or equivalent).

AANEM recommends physician-performed needle EMG and physician supervision of NCS; direct supervision is required when technologists perform testing.
One physician should supervise and perform all components of the exam when feasible; real-time integration of history, examination, testing, and interpretation is preferred.
Technologists may perform delegated NCS/SEP testing when selected by the physician, but the physician must review results and be available for unexpected findings.

Documentation Required

Required clinical documentation

Documentation must support the differential diagnosis, list which NCS and EMG components were performed, and include device/model and placement for wearable or sEMG devices. For QST and related devices, document instrument/methodology, calibration, and testing protocol.

Include history, physical exam findings, and clinical indications that justify the selected electrodiagnostic tests.
Specify which nerves/muscles were tested, parameters recorded, and whether F-waves, H-reflexes, or SEP testing were performed.
For wearable seizure or sEMG devices, document device model, FDA clearance status, electrode/placement site, and who reviewed stored data.
For QST: record the specific instrument, stimulus modality, calibration verification, testing protocol, normative values used, and patient cooperation/limitations.

Documentation Required

QST instrument and protocol documentation

When using Quantitative Sensory Testing (QST) in clinical care, employ only instruments and methodologies demonstrated to be reproducible; follow strict calibration and testing protocols and document them.

QST results depend on full patient cooperation and specific device/methodology; thermal thresholds may be less reproducible than vibration thresholds.
Record machine calibration, thermode size, stimulus characteristics, algorithm used, normative values, and testing protocol; include reproducibility considerations in the documentation.
QST should not be used to localize lesions; interpret results in context of clinical exam and other objective testing.

Documentation Required

Device use and documentation

For FDA-cleared sEMG or other seizure monitoring devices, include device model, placement (e.g., upper arm biceps, wrist), alert/notification configuration, and any device-specific limitations or adverse events in the medical record and prior authorization submission.

Document whether device was used as adjunctive monitoring during rest or in supervised settings, and whether recorded data were reviewed by a trained healthcare professional.
Record any adverse device events (e.g., skin irritation) and any device-related withdrawals or tolerability issues.
Include how device output informed clinical management or safety planning.

Note

Reference benefit plan terms

This policy is informational and does not replace the member's federal, state, or contractual benefit terms. Always reference the applicable benefit plan when determining coverage or prior authorization requirements.

If federal, state, or contract provisions conflict with this policy, the benefit terms govern.
Verify prior authorization requirements with the member's UnitedHealthcare benefit plan; prior authorization may be required for wearable sEMG seizure monitoring systems depending on plan terms.

Note

QST methodology first-line consideration

When considering QST, prioritize methodologies and instruments with demonstrated reproducibility and follow calibration/test protocols as a first-line methodological consideration.

Do not rely on QST instruments without established reproducibility for clinical decisions.
Include reproducibility data or rationale when requesting authorization for QST in clinical management.

Electromyography (EMG)

DefinitionMeasurement of muscle electrical activity using needle (NEMG) or surface (SEMG) electrodes

Needle EMGInvolves insertion of intramuscular needle electrodes to evaluate muscle and motor unit function

Surface EMGNoninvasive electrodes placed on the skin to record underlying muscle electrical activity; used for monitoring or analytic purposes

SupervisionNeedle EMG should be performed by a physician specially trained in electrodiagnostic medicine; data collection supervised by EDX physician per AANEM

Quantitative sensory testing (QST)

DefinitionObjective assessments of peripheral sensory function using vibration, touch‑pressure, heat or cold stimuli

Methods/examplesMonofilament (Weinstein‑Semmes), CASE IV, Medoc systems, Vibratron, Biothesiometer; CPT sNCT/CPT current perception threshold methods

Clinical roleMay document sensory threshold changes and longitudinal diabetic neuropathy assessment, but results are methodology‑dependent

LimitationsWeak overall evidence and reproducibility concerns; QST should not be sole diagnostic method

Real time on-site — Real-time (onsite) interpretation definition

DefinitionOnsite, real‑time interpretation integrates history, tailored testing, waveform analysis and interpretation while the patient is present

AANEM positionPreferred that needle EMG and NCS be conducted and interpreted on‑site in real time in the majority of situations

Operational implicationPhysician reviews waveforms and may adjust testing during the encounter

Qualified EDX physician

DefinitionPhysician with specialized training in electrodiagnostic (EDX) medicine (e.g., neurologist or physiatrist) or equivalently trained individual under direct supervision

Demonstration of qualificationAppropriate neurology or PMR residency/fellowship training and certification (eg, ABEM) or equivalent documented experience

Supervisory roleEDX physician should supervise data collection, interpretation and be immediately available during testing

Wearable sensor systems

DefinitionDevices containing accelerometers, electromyography sensors, or smartphone inertial sensors used to passively or actively record motor activity

ExamplesKinesia, Personal Kinetigraph (PKG), Tremorometer, smartphone‑based sensors and hybrid patches (accelerometer + EMG)

Intended outputAlgorithmic measures of symptom severity, gait, tremor frequency/amplitude, and longitudinal motor fluctuation data

Evidence noteFeasibility and moderate‑to‑excellent reliability reported in small studies; clinical outcome benefit not consistently established

Quantitative Sensory Testing (QST)

DefinitionPsychophysical testing measuring sensory thresholds (vibration, thermal, pain) to assess large‑ and small‑fiber function and central pain processing

ModalitiesVibration, thermal (heat/cold), touch‑pressure, current perception threshold (CPT)/sNCT methods

Recommended useMay be useful for documenting changes in diabetic neuropathy (Level B AAN) but not as a standalone diagnostic test

Surface Electromyography (SEMG)

DefinitionNoninvasive recording of muscle electrical activity via surface electrodes

ApplicationsMonitoring, diagnostic, or analytic purposes including seizure detection and respiratory muscle monitoring (research/monitoring contexts)

Evidence limitationsOverall evidence is weak for many clinical applications; standardized methods and diagnostic accuracy data are lacking

Regulatory noteSome SEMG systems have FDA de novo/clearance for adjunctive seizure monitoring (eg, SPEAC) or other uses

SPEAC System

DeviceSPEAC System (Brain Sentinel) — sEMG‑based wearable worn over upper‑arm biceps for adjunctive detection of generalized tonic‑clonic seizures

IndicationAdjunctive seizure monitoring in adults at home or in healthcare facilities during periods of rest

FunctionAnalyzes sEMG signals associated with GTCS and records/stores data for review by trained healthcare professionals

Embrace

DeviceEmbrace (Empatica) — wrist‑worn device sensing electrodermal activity, motion, and temperature for seizure adjunctive monitoring

IndicationAdjunct to seizure monitoring of adults in home or healthcare facilities during periods of rest for detection of generalized tonic‑clonic seizures

FunctionSenses EDA and motion; sends alert to paired device to notify designated caregiver; records accelerometer, EDA and temperature data for review

Personal Kinetigraph (PKG)

DevicePersonal Kinetigraph (PKG) — wrist‑worn system to quantify kinematics of movement disorder symptoms

Intended useContinuous ambulatory monitoring of tremor, bradykinesia and dyskinesia; includes medication reminder and event marker

Typical wear durationWorn for 6 to 10 days to provide continuous assessment

FDA statusReceived FDA 510(k) clearance (August 22, 2014)

Kinesia

DeviceKinesia — compact wireless quantitative motor assessment using accelerometers and gyroscopes

Form factorWorn on wrist and finger to monitor upper extremity movement and fluctuations

PurposeQuantify tremor and other kinematic movement features for monitoring and assessment of movement disorders

Embrace (Empatica)

DeviceEmbrace (Empatica) — wrist‑worn adjunctive seizure monitoring device sensing EDA, motion and temperature

Regulatory statusFDA approved (January 2018) for adjunct seizure monitoring in adults during periods of rest

FunctionDetects patterns associated with generalized tonic‑clonic seizures and alerts caregivers; records data for clinician review

Previous policy version CSO82NM.A was archived concurrent with the April 1, 2025 updates.