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The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system
designed to monitor and analyze electromyography (EMG) data to detect the onset
of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with
secondary generalization and to provide a warning signal to alert caregivers that a
seizure is occurring. The system records EMG data (24/7) and is available for analysis
of other motor events.
The Brain Sentinel Seizure Detection and Warning System is intended for monitoring
adults with a history or significant risk of generalized tonic-clonic seizures in the
home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,
and for continuous monitoring, night time or any other time of day, of individuals due
to their history or risk of generalized tonic-clonic seizures and will withstand activities
of daily living including showers and sleep. The Brain Sentinel Seizure Detection and
Warning System is available by prescription only.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900440 ()
SPC15-90044
- Home seizure monitoring system
CORXT
The Peerbridge Cor™ System is a family of products comprised of two models, the
Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The
system is an ambulatory wearable ECG monitoring system designed to record and
provide patient's electrocardiogram (ECG) data to the clinician.
The Peerbridge System consists of five components: (1) Wearable ECG Sensor with
Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter
Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from
the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based
Backend Data Management Module. The Wearable ECG sensor attaches to the patient's
chest and records the patient's ECG continuously. This device can collect two (2)
channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,
patients can report symptomatic events by pressing the Event Button on the Wearable
ECG Sensor or by using the mobile application on the Handheld Transmitter when a
symptom is experienced. The device generates ECG reports to be displayed on the
clinician's interface.
The Peerbridge System Cor XT is configured for the following:
- 24 hours of Holter monitoring
and
- Up to 7 days of Holter Monitoring
PEERBRIDGE HEALTH, INC.
CORXT
In Commercial Distribution
- B608CORXT1 ()
- B608CORXT0 ()
CORXT
- Wearable multiple physiological parameter recorder, reusable
COREVENT
The Peerbridge Cor™ System is a family of products comprised of two models, the
Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The
system is an ambulatory wearable ECG monitoring system designed to record and
provide patient's electrocardiogram (ECG) data to the clinician.
The Peerbridge System consists of five components: (1) Wearable ECG Sensor with
Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter
Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from
the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based
Backend Data Management Module. The Wearable ECG sensor attaches to the patient's
chest and records the patient's ECG continuously. This device can collect two (2)
channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,
patients can report symptomatic events by pressing the Event Button on the Wearable
ECG Sensor or by using the mobile application on the Handheld Transmitter when a
symptom is experienced. The device generates ECG reports to be displayed on the
clinician's interface.
The Peerbridge System Cor Event is configured for the following:
- 24 hours of Holter monitoring
- Patient Activated Event with Surveillance
PEERBRIDGE HEALTH, INC.
COREVENT
In Commercial Distribution
- B608COREVENT0 ()
- B608COREVENT1 ()
COREVENT
- Wearable multiple physiological parameter recorder, reusable
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records
and stores data for review by a physician for characterization of seizure events.
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with
an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC
seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that
may be associated with such seizures are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare
professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that
their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced
with the second sEMG Monitor on the opposite arm of the patient.
The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the
sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base
Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,
Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured
within Microsoft Azure which is FedRAMP certified.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900551 ()
SPC15-90055
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records
and stores data for review by a physician for characterization of seizure events.
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with
an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC
seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that
may be associated with such seizures are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare
professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that
their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced
with the second sEMG Monitor on the opposite arm of the patient.
The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the
sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base
Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,
Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured
within Microsoft Azure which is FedRAMP certified.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900541 ()
SPC15-90054
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records
and stores data for review by a physician for characterization of seizure events.
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with
an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC
seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that
may be associated with such seizures are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare
professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that
their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced
with the second sEMG Monitor on the opposite arm of the patient.
The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the
sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base
Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,
Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured
within Microsoft Azure which is FedRAMP certified.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900431 ()
SPC15-900431
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records
and stores data for review by a physician for characterization of seizure events.
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with
an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC
seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that
may be associated with such seizures are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare
professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that
their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced
with the second sEMG Monitor on the opposite arm of the patient.
The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the
sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base
Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,
Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured
within Microsoft Azure which is FedRAMP certified.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900430 ()
SPC15-90043
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records
and stores data for review by a physician for characterization of seizure events.
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with
an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC
seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that
may be associated with such seizures are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare
professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that
their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced
with the second sEMG Monitor on the opposite arm of the patient.
The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the
sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base
Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,
Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured
within Microsoft Azure which is FedRAMP certified.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900181 ()
SPC15-90018
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records
and stores data for review by a physician for characterization of seizure events.
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with
an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC
seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that
may be associated with such seizures are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare
professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that
their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced
with the second sEMG Monitor on the opposite arm of the patient.
The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the
sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base
Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,
Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured
within Microsoft Azure which is FedRAMP certified.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900180 ()
SPC15-90018
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.
Page 2 of 13
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.
The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900580 ()
SPC15-90058
- Home seizure monitoring system