Purpose-Built
Go Anywhere
Vital Signs

Halo™ is FDA-cleared under K232495 for SpO₂, pulse rate, respiratory rate, core body temperature, skin temperature, activity level, step count, body posture, and fall detection. These cleared parameters are available for adult patients 22 years of age and older, including during motion, trauma, military field operations, and all ambulance types.

Under FDA review and not currently cleared: heart rate via ECG, ECG QRS identification, cardiac arrhythmia detection (AFib, VFib, VEB, SVEB), HRV, RR intervals, SCG IJK identification, JJ intervals, pulse deficit, VO₂ max, non-invasive blood pressure (NIBP), HaloCRM™ compensatory reserve measurement, PTT, PAT, PWV, PEP, ECG ST and QT monitoring, impedance respiration, and seismocardiography (SCG).

The Halo™ device weighs 17 grams, approximately 0.6 ounces. It is small enough to fit inside a standard IFAK pouch and is worn at the back of the earlobe and the soft tissue pocket on the neck. No other FDA-cleared multi-parameter wearable patient monitor in its class matches this size and weight profile.

Halo™ provides up to 110 hours of continuous battery life on a single charge. The battery capacity is 400 mAh and recharges from empty to full in approximately 80 minutes. This battery life supports extended operations in prolonged field care and remote patient monitoring settings where resupply cannot be assumed.

Halo™ uses Bluetooth Low Energy (BLE) 5.0 Long Range and has demonstrated a range of 1.1 miles in field testing. In typical operational environments, effective range will vary based on terrain, obstructions, and RF conditions. For use in contested electromagnetic environments, Halo™ also supports NFMI (near-field magnetic induction) and hardwired cable connections with zero RF signature.

Halo™ is manufactured in the United States. Sempulse uses a US-based contract manufacturer and maintains a supply chain composed primarily of US and allied-nation components. The only non-domestic component is the lithium battery, and Sempulse holds a reserve inventory of more than 10,000 batteries. Current production capacity is 10,000 units per month, scalable upward at Sempulse's direction.

Halo™ applies in under 10 seconds and produces first vital signs within approximately 15 seconds of power-on. The full vital signs suite is available within 75 seconds. No calibration, skin preparation, gel, or hair removal is required. The device is operable with gloved hands. A medic can achieve proficiency in 30 minutes; non-medical personnel can achieve proficiency in under 10 minutes.

Halo™ stores 1 gigabit of data onboard, which supports approximately 17 months of continuous vital signs data at 1 Hz with data compression. This offline storage capacity allows Halo™ to operate fully in disconnected, degraded, intermittent, and limited (DDIL) environments, caching all data locally and syncing automatically when connectivity is restored.

Yes. Halo™ carries an IP67 ingress protection rating, meaning it is rated for submersion in up to 1 meter of water for 30 minutes. It is also MIL-STD-810 validated for military environmental conditions including temperature extremes, shock, vibration, humidity, and altitude. The operating temperature range is -40°F to 158°F (-40°C to 70°C).

The Sempulse Point is the proprietary placement site for the Halo™ neck sensor: the soft tissue pocket between the scalene muscles, directly below the ear canal and adjacent to the carotid artery. This location provides stable, motion-tolerant access to cardiovascular signals at a central vascular site, maintaining signal fidelity under physiologic stress and trauma where extremity-based monitors lose accuracy.

Cardiac arrhythmia detection including AFib, VFib, VEB, and SVEB is under FDA review and not currently cleared. Halo captures a two-lead ECG signal with one wet electrode at the neck and one dry stainless steel electrode at the ear, and the device is designed to support arrhythmia detection as part of its ECG suite. However, this capability is not among the currently cleared outputs under K232495 and cannot be used or represented as a cleared diagnostic function.

Halo™ uses red (660nm) and infrared (880nm) PPG optical sensors at the ear, a site that maintains central vascular perfusion under physiologic stress and motion where wrist and fingertip sensors lose accuracy due to peripheral vasoconstriction. FDA-cleared SpO₂ accuracy during motion is ≤3.0% A_RMS. The FDA has formally stated that extremity-based monitors are not appropriate for trauma monitoring for this reason. Halo's placement at the ear and neck avoids this limitation by design.

Yes. Halo™ is designed to be worn simultaneously with helmets, night vision goggles (NVGs), hearing protection, in-ear communications devices, ballistic eyewear, and body armor. The ear sensor attaches to the back of the cavum concha and does not interfere with the ear canal or standard military audio equipment. The neck sensor placement is compatible with all standard military collar configurations and MOPP gear.

A standard pulse oximeter measures SpO₂ and pulse rate at a fingertip or wrist and loses accuracy during motion, cold temperatures, and physiologic stress due to peripheral vasoconstriction. Halo™ is a multi-parameter wearable measuring more than 20 vital sign parameters continuously from the ear and neck, sites that maintain central vascular perfusion under stress. It is FDA-cleared for trauma, military field operations, and all ambulance types, settings where standard pulse oximeters are explicitly not indicated.

A single LiveCharts instance on a modern iOS or Android device supports 8 to 15 concurrent Halo™ devices simultaneously. Multiple LiveCharts instances aggregate on Command Cloud for command-level visibility across an unlimited number of patients. All monitored patients are automatically ranked by acuity severity every second, with the most critical patient always at the top of the display. In a documented military exercise (NSW MASCAL, n=22), a 9-Line MEDEVAC event was reduced from 28 minutes to under 5 minutes using the Halo™ platform.

Yes. Halo™ is fully DDIL-capable: disconnected, degraded, intermittent, and limited environments. The device stores up to 17 months of vital signs data onboard at 1 gigabit with data compression. LiveCharts operates fully offline, caching all patient data locally and syncing automatically to Command Cloud when connectivity is restored. No internet connection is required for continuous vital signs monitoring and alerting.

Yes. The Halo™ base unit and ear sensor are reusable across multiple patients with a simple alcohol wipe between uses. The device is rated for 300 to 500 charge cycles. The disposable component is the ECG electrode adhesive used at the neck placement site, which is a standard single-use medical electrode. This reusable design significantly reduces per-patient cost in high-volume or mass casualty settings.

Halo™ integrates with MHS GENESIS EHR (bidirectional data flow validated by NMFP CMIO), ATAK, WinTAK, iTAK, BATDOK-J, JOMIS OpMed Care Delivery Platform, TMDS, OMDS, ALTA, NGC2, Nett Warrior, Blue Force Tracker, CINTAK, and Microsoft HoloLens. Command Cloud uses a MOSA architecture with open API and SDK access for integration with any additional system or data fabric.

HaloCRM™ is Sempulse's compensatory reserve measurement capability, licensed from the U.S. Army Institute of Surgical Research (USAISR) and running at the tactical edge on the Halo™ device. Compensatory reserve measures the physiologic reserve being consumed by the body's hemorrhage compensation response, detecting hemodynamic deterioration earlier than blood pressure or other vital signs alone per published clinical research. HaloCRM™ is under FDA review and not currently cleared.

Halo™ is validated for all Fitzpatrick skin types (I through VI) and all ear sizes. The PPG optical sensors auto-adjust LED intensity for skin pigmentation. This validation was completed as part of the FDA 510(k) K232495 clearance process and is explicitly included in the cleared indications. The device is designed to perform consistently across the full range of human physiologic variation encountered in military and clinical populations.

Halo™ is FDA-cleared under K232495 for adult patients 22 years of age and older. Use in patients under 22 years of age is outside the current cleared indications. Sempulse's ongoing regulatory program may address additional patient populations in future submissions. Federal law restricts this device to sale by or on the order of a physician.

Yes, emphatically. The Sempulse Halo™ monitor holds FDA 510(k) clearance K232495. FDA-cleared parameters include SpO₂, pulse rate, respiratory rate, core body temperature, skin temperature, activity, posture, and fall detection, and for use in motion, military field operations, trauma, and all ambulance types. Non-invasive blood pressure (NIBP), HaloCRM™, heart rate via ECG, ECG QRS identification, arrhythmia detection, HRV, SCG, PTT, PAT, PWV, PEP, pulse deficit, VO₂ max, and SCG are under FDA review and not currently cleared.

Yes, explicitly and as a central feature of the FDA clearance. K232495 covers Halo™ for trauma scenarios, triage, motion, military field operations, and all ambulance types. The device has been tested to MIL-STD-810 military environmental standards and is validated for all Fitzpatrick skin types and all ear sizes. SpO₂ accuracy during motion is ≤3.0% ARMS. SCG JJ interval accuracy during motion is ±4 ms.

The FDA has formally stated that extremity-based monitors are not appropriate for trauma monitoring because physiologic stress shunts blood away from extremities. Halo™ places sensors at the ear and neck, which maintain perfusion under trauma and stress, specifically to avoid this limitation.

FDA-cleared (K232495) for adult patients 22 years of age and older: SpO₂ (≤1.9% ARMS), pulse rate (±3 BPM), respiratory rate (±2 ARMS), core body temperature (±0.3°C), skin temperature (±0.3°C), activity level, step count, posture, and fall detection.

Under FDA review (not currently cleared): Non-invasive blood pressure (NIBP), HaloCRM™ compensatory reserve measurement, PTT/PAT/PWV/PEP pulse timing metrics, ECG ST/QT monitoring, impedance respiration, and seismocardiography (SCG).

Cardiac arrhythmia detection including AFib, VFib, VEB, and SVEB is under FDA review and not currently cleared. Halo™ captures a two-lead ECG signal with one wet electrode at the neck and one dry stainless steel electrode at the ear, and the device is designed to support arrhythmia detection as part of its ECG suite. However, this capability is not among the currently cleared outputs under K232495 and cannot be used or represented as a cleared diagnostic function. HRV, RR intervals, and SCG-derived timing metrics are also under FDA review and not currently cleared.

Yes, and this is one of the most clinically meaningful features of continuous wearable monitoring. Sleep is among the most powerful recovery tools available to patients and clinicians. Disrupting sleep to manually check vital signs costs the patient recovery time, elevates stress hormones, fragments sleep architecture, and introduces unnecessary discomfort and handling.

Halo™ monitors continuously and silently while the patient sleeps. Clinicians receive auditory or visual alerts only when a threshold is crossed. Silent mode disables auditory alarms while maintaining full visual alert functionality, allowing undisturbed patient rest while maintaining clinical vigilance. In prolonged field care, home healthcare, hospital recovery, and rehabilitation settings, the ability to monitor every vital sign without waking the patient is not just convenient: it is better clinical care.

LiveCharts supports an unlimited number of simultaneous patients across multiple app instances. Each LiveCharts instance on a modern iOS or Android device supports 8 to 15 concurrent Halo™ devices. Multiple LiveCharts instances are aggregated on Command Cloud for command-level visibility across an entire mass casualty event. Patients are automatically ranked by acuity severity every second, with the most critical patient always at the top of the display. In a documented military exercise (NSW MASCAL, n=22), a 3-person MASCAL 9-Line MEDEVAC event was reduced from 28 minutes to under 5 minutes using the Halo™ platform.

Yes. Halo™ integrates natively with ATAK/WinTAK/iTAK, BATDOK-J, JOMIS OpMed Care Delivery Platform, MHS GENESIS EHR (bidirectional data flow validated by NMFP CMIO), TMDS/OMDS/ALTA, NGC2, Nett Warrior, Blue Force Tracker, and CINTAK. The MOSA architecture allows integration with any additional data fabric via API or SDK. Command Cloud integrates with MHS GENESIS, Blue Force Tracker, and NGC2 for aggregate clinical and operational data access.

Halo™ holds FDA 510(k) clearance K232495, IP67 water resistance (1 meter for 30 minutes), MIL-STD-810 validation, and airworthiness validation by Intertek. The operating temperature range is -40°F to 158°F (-40°C to 70°C). The device complies with more than 32 standards including IEC 60601-1 general medical electrical safety, IEC 60601-1-8 alarm standards, IEC 60601-1-12 emergency medical services environment, IEC 60601-2-47 ambulatory ECG, ISO 80601-2-61 pulse oximetry, and ISO 80601-2-56 thermometry.