{ "id": "AIBD-0296", "title": "Empatica Embrace seizure alert reaches Morgan McGrath's mother, who calls paramedics after a seizure left the 26-year-old teacher not breathing (Fulton, Missouri)", "summary": "IEEE Spectrum (6 February 2018): an Embrace wristband alerted the mother of Morgan McGrath, 26, of Fulton, Mo., during a seizure about 15 months earlier; she called paramedics and McGrath survived.", "date_observed": "2018-02-06", "date_basis": "unassessed", "date_precision": "unassessed", "benefit_status": null, "source_collection": null, "source_entry": null, "account": "Elie Dolgin reported in IEEE Spectrum on 6 February 2018 on Morgan McGrath, a 26-year-old teacher from Fulton, Missouri. She “suffered an epileptic seizure that left her unresponsive, frothing at the mouth, with blue lips, and not breathing”. The article dates the seizure to “fifteen months ago”, about November 2016. Her wrist-worn Embrace device alerted her mother, who called the paramedics, and “thanks to a timely response, McGrath is alive and well today”. The article says it records skin conductance and three-axis accelerometer data and “uses a proprietary algorithm to signal when someone is having a convulsive seizure”. The app sends a text or call to pre-specified caregivers. In testing on 135 patients over more than 6,500 hours it “correctly identified nearly every single seizure”. The Food and Drug Administration (FDA) cleared Embrace (Empatica S.r.l.) under 510(k) K172935 on 26 January 2018, after the McGrath event. The 510(k) summary describes an on-board algorithm validated against video electroencephalography (EEG). On detecting a likely generalized tonic-clonic seizure, it messages the Alert app to call and text designated caregivers. A later prospective multicenter study (Onorati et al. 2021) by Empatica staff with hospital co-authors reports sensitivity for a predefined machine-learning algorithm. It was 0.92 in children and 0.94 in adults. An independent Montreal epilepsy-monitoring-unit study (Jahani et al. 2026) found the Embrace2 detected all 16 convulsive seizures while worn and working. Alerts reached caregivers in 15 of 16 cases, with 29 false alarms. The McGrath rescue rests on this single news item. The Empatica case-study abstract (Regalia, Onorati, Picard, American Epilepsy Society) is not among the sources. No second account of the McGrath event was found.", "category": "protective response", "unexpected": false, "purpose": "Built to detect convulsive seizures from electrodermal activity and motion and to summon designated caregivers. The alert to McGrath's mother was that purpose.", "system": "Empatica Embrace wrist-worn seizure detection (electrodermal activity and accelerometer, on-board algorithm) with the Alert smartphone app", "model_version": "Embrace (the article does not state the generation); echoes concern Embrace2", "developer": "Empatica", "deployer": null, "location": "Fulton, Missouri, United States", "domain": "Healthcare (epilepsy; seizure monitoring)", "segment": "Prescription wearable seizure monitor used at home", "benefit_type": "Improved Physical Health", "taxonomy_note": null, "registry_ids": {}, "ratings": [ { "group": "personal", "depth": 3, "reason": "A young woman not breathing during a seizure had paramedics summoned by her mother on the device's alert and is reported alive and well. A potentially life-saving response documented only in one news report." } ], "ai_role": { "status": "assessed", "statement": "Per IEEE Spectrum, the Embrace detected the seizure and its app alerted McGrath's mother, who made the emergency call. The device did not call for help itself. The article calls the algorithm proprietary. The FDA summary describes it as an on-board algorithm validated against video-EEG. Empatica's own 2021 study calls it a predefined machine-learning algorithm. The McGrath event is known only from this single news item. The AES case-study abstract is not among the sources." }, "evidence": [ { "kind": "news report", "citation": "Dolgin E (2018). This Seizure-Detecting Smartwatch Could Save Your Life. IEEE Spectrum, 6 February 2018.", "title": "This Seizure-Detecting Smartwatch Could Save Your Life", "url": "https://spectrum.ieee.org/this-seizuredetecting-smartwatch-could-save-your-life", "date": "2018-02-06", "written_by": "independent", "quote": "McGrath's wristworn Embrace device sent her mother an alert. Her mother called the paramedics." }, { "kind": "news report", "citation": "Dolgin E (2018), IEEE Spectrum, 6 February 2018 (on the seizure).", "title": "This Seizure-Detecting Smartwatch Could Save Your Life", "url": "https://spectrum.ieee.org/this-seizuredetecting-smartwatch-could-save-your-life", "date": "2018-02-06", "written_by": "independent", "quote": "Fifteen months ago, the 26-year-old teacher from Fulton, Mo., suffered an epileptic seizure that left her unresponsive, frothing at the mouth, with blue lips, and not breathing." }, { "kind": "regulatory document", "citation": "U.S. Food and Drug Administration (2018). 510(k) Summary K172935, Embrace, Empatica S.r.l.; decision 26 January 2018 (text extracted from the PDF).", "title": "510(k) Summary K172935: Embrace", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172935.pdf", "date": "2018-01-26", "written_by": "makers", "quote": "When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers." }, { "kind": "peer-reviewed study", "citation": "Onorati F, Regalia G, Caborni C, LaFrance WC Jr, Blum AS, Bidwell J, De Liso P, El Atrache R, Loddenkemper T, Mohammadpour-Touserkani F, Sarkis RA, Friedman D, Jeschke J, Picard R (2021). Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit. Frontiers in Neurology 12:724904 (PMC8418082). Lead authors at Empatica, Inc.", "title": "Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/", "date": "2021-08-18", "written_by": "makers", "quote": "A prospective study was conducted for the FDA clearance of an ACM and EDA-based CS-detection device based on a predefined machine learning algorithm." }, { "kind": "peer-reviewed study", "citation": "Jahani A, Galindo Lazo DA, Sarzo Wabi I, Gharbi O, Robert M, Millan JP, D'Onofrio G, Robin A, Nguyen DK, Bou Assi E (2026). Prospective evaluation of a seizure detection wearable device for timely interventions in an epilepsy monitoring unit. Epilepsia 67(4):1802-1816 (PMC13075604).", "title": "Prospective evaluation of a seizure detection wearable device for timely interventions in an epilepsy monitoring unit", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/", "date": "2026-01-07", "written_by": "independent", "quote": "Alerts successfully reached caregivers in 15 of 16 cases, with one failure due to a Wi‐Fi disconnection." } ], "replication": { "produced_by": [ "A convulsive (generalized tonic-clonic) seizure, the only type the device is cleared to detect", "The wristband worn and paired with a phone running the Alert app, with a caregiver designated", "A caregiver able to reach the patient or call emergency services on receiving the alert" ], "must_hold": [ "Connectivity between watch, phone and caregiver (one of 16 alerts in Montreal failed on a Wi-Fi disconnection)", "Caregivers tolerate false alarms (29 in 373 monitoring days in Montreal, mostly from routine movements)", "Focal seizures without convulsions are not detected (none of 510 in Montreal)" ], "echoes": [ { "date": "2026-01-07", "setting": "Center hospitalier de l'Université de Montréal epilepsy monitoring unit, 72 patients, April 2024 to June 2025; alerts routed to nursing staff", "model_version": "Embrace2", "outcome": "recurred", "source": "Jahani et al. (2026) Epilepsia 67(4):1802-1816, https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/ (quote: 'The Embrace2 wrist‐worn device detected all 16 FBTCSs/GTCSs that occurred while the device was functioning and worn, but none of 510 FSs.')" }, { "date": "2021-08-18", "setting": "Multicentre epilepsy-monitoring-unit study, 152 patients (85 children), 66 convulsive seizures; detection performance only, no home alerts", "model_version": null, "outcome": "recurred", "source": "Onorati et al. (2021) Front Neurol 12:724904, https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/ (sensitivity 0.92 pediatric, 0.94 adult; false alarm rate 1.26 and 0.57 per 24 h)" } ] }, "paired_incident": null, "headline": "Empatica Embrace seizure alert reaches Morgan McGrath's mother", "metric": null, "comparator": { "against": "seizures recorded during more than 6,500 hours of monitoring of 135 patients (device test reported by IEEE Spectrum)", "before": null, "after": "the device correctly identified nearly every single seizure, with a false alarm rate below that of the seizure frequency for most individuals", "basis": "measured", "quote": "When tested on 135 patients who were monitored for a collective total of more than 6,500 hours, the device correctly identified nearly every single seizure, with a false alarm rate below that of the seizure frequency for most individuals.", "url": "https://spectrum.ieee.org/this-seizuredetecting-smartwatch-could-save-your-life" }, "later": { "status": "persisted", "date": "2026-01-07", "note": "An independent Montreal epilepsy-monitoring-unit study later found the Embrace2 detected all 16 convulsive seizures that occurred while worn and working, with alerts reaching caregivers in 15 of 16 cases and 29 false alarms over the study.", "quote": "Alerts successfully reached caregivers in 15 of 16 cases, with one failure due to a Wi‐Fi disconnection.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/" }, "value": null, "developer_country": "United States", "deployer_country": null, "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, what happened since from the cited sources.", "source": "https://spectrum.ieee.org/this-seizuredetecting-smartwatch-could-save-your-life; https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Empatica", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Notes about which sources could be read were reworded for readers; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" } ], "confidence": "studied", "shade": "high", "claim_status": "Independently studied", "claim_basis": "Sources: one independent peer-reviewed study, one independent news report, the makers' regulatory document and the makers' peer-reviewed study. 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Physical Health" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "benefit_type" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].claim": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "account": "Elie Dolgin reported in IEEE Spectrum on 6 February 2018 on Morgan McGrath, a 26-year-old teacher from Fulton, Missouri. She “suffered an epileptic seizure that left her unresponsive, frothing at the mouth, with blue lips, and not breathing”. The article dates the seizure to “fifteen months ago”, about November 2016. Her wrist-worn Embrace device alerted her mother, who called the paramedics, and “thanks to a timely response, McGrath is alive and well today”. The article says it records skin conductance and three-axis accelerometer data and “uses a proprietary algorithm to signal when someone is having a convulsive seizure”. The app sends a text or call to pre-specified caregivers. In testing on 135 patients over more than 6,500 hours it “correctly identified nearly every single seizure”. The Food and Drug Administration (FDA) cleared Embrace (Empatica S.r.l.) under 510(k) K172935 on 26 January 2018, after the McGrath event. The 510(k) summary describes an on-board algorithm validated against video electroencephalography (EEG). On detecting a likely generalized tonic-clonic seizure, it messages the Alert app to call and text designated caregivers. A later prospective multicenter study (Onorati et al. 2021) by Empatica staff with hospital co-authors reports sensitivity for a predefined machine-learning algorithm. It was 0.92 in children and 0.94 in adults. An independent Montreal epilepsy-monitoring-unit study (Jahani et al. 2026) found the Embrace2 detected all 16 convulsive seizures while worn and working. Alerts reached caregivers in 15 of 16 cases, with 29 false alarms. The McGrath rescue rests on this single news item. The Empatica case-study abstract (Regalia, Onorati, Picard, American Epilepsy Society) is not among the sources. No second account of the McGrath event was found.", "benefit_type": "Improved Physical Health" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "account", "benefit_type" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].distribution": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].duration": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].id": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].stakeholder_group": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "depth": 3, "reason": "A young woman not breathing during a seizure had paramedics summoned by her mother on the device's alert and is reported alive and well. 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The alert to McGrath's mother was that purpose." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "unexpected", "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "places[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "location": "Fulton, Missouri, United States", "developer_country": "United States" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "location", "developer_country" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "Built to detect convulsive seizures from electrodermal activity and motion and to summon designated caregivers. 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(2026) Epilepsia 67(4):1802-1816, https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/ (quote: 'The Embrace2 wrist‐worn device detected all 16 FBTCSs/GTCSs that occurred while the device was functioning and worn, but none of 510 FSs.')" }, { "date": "2021-08-18", "setting": "Multicentre epilepsy-monitoring-unit study, 152 patients (85 children), 66 convulsive seizures; detection performance only, no home alerts", "outcome": "recurred", "source": "Onorati et al. (2021) Front Neurol 12:724904, https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/ (sensitivity 0.92 pediatric, 0.94 adult; false alarm rate 1.26 and 0.57 per 24 h)" } ] } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "replication" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "replication.conditions": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "replication": { "produced_by": [ "A convulsive (generalized tonic-clonic) seizure, the only type the device is cleared to detect", "The wristband worn and paired with a phone running the Alert app, with a caregiver designated", "A caregiver able to reach the patient or call emergency services on receiving the alert" ], "must_hold": [ "Connectivity between watch, phone and caregiver (one of 16 alerts in Montreal failed on a Wi-Fi disconnection)", "Caregivers tolerate false alarms (29 in 373 monitoring days in Montreal, mostly from routine movements)", "Focal seizures without convulsions are not detected (none of 510 in Montreal)" ], "echoes": [ { "date": "2026-01-07", "setting": "Center hospitalier de l'Université de Montréal epilepsy monitoring unit, 72 patients, April 2024 to June 2025; alerts routed to nursing staff", "model_version": "Embrace2", "outcome": "recurred", "source": "Jahani et al. (2026) Epilepsia 67(4):1802-1816, https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/ (quote: 'The Embrace2 wrist‐worn device detected all 16 FBTCSs/GTCSs that occurred while the device was functioning and worn, but none of 510 FSs.')" }, { "date": "2021-08-18", "setting": "Multicentre epilepsy-monitoring-unit study, 152 patients (85 children), 66 convulsive seizures; detection performance only, no home alerts", "outcome": "recurred", "source": "Onorati et al. (2021) Front Neurol 12:724904, https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/ (sensitivity 0.92 pediatric, 0.94 adult; false alarm rate 1.26 and 0.57 per 24 h)" } ] } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "replication" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "revision_history[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, what happened since from the cited sources.", "source": "https://spectrum.ieee.org/this-seizuredetecting-smartwatch-could-save-your-life; https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Empatica", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Notes about which sources could be read were reworded for readers; facts, figures and quotations unchanged.", "editor": "AIBD" } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "revisions" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sector": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "domain": "Healthcare (epilepsy; seizure monitoring)", "segment": "Prescription wearable seizure monitor used at home" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "domain", "segment" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sources[].access_version": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "sources[].citation_locator": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "news report", "citation": "Dolgin E (2018). 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Her mother called the paramedics." }, { "kind": "news report", "citation": "Dolgin E (2018), IEEE Spectrum, 6 February 2018 (on the seizure).", "title": "This Seizure-Detecting Smartwatch Could Save Your Life", "url": "https://spectrum.ieee.org/this-seizuredetecting-smartwatch-could-save-your-life", "date": "2018-02-06", "written_by": "independent", "quote": "Fifteen months ago, the 26-year-old teacher from Fulton, Mo., suffered an epileptic seizure that left her unresponsive, frothing at the mouth, with blue lips, and not breathing." }, { "kind": "regulatory document", "citation": "U.S. Food and Drug Administration (2018). 510(k) Summary K172935, Embrace, Empatica S.r.l.; decision 26 January 2018 (text extracted from the PDF).", "title": "510(k) Summary K172935: Embrace", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172935.pdf", "date": "2018-01-26", "written_by": "makers", "quote": "When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers." }, { "kind": "peer-reviewed study", "citation": "Onorati F, Regalia G, Caborni C, LaFrance WC Jr, Blum AS, Bidwell J, De Liso P, El Atrache R, Loddenkemper T, Mohammadpour-Touserkani F, Sarkis RA, Friedman D, Jeschke J, Picard R (2021). Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit. Frontiers in Neurology 12:724904 (PMC8418082). Lead authors at Empatica, Inc.", "title": "Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/", "date": "2021-08-18", "written_by": "makers", "quote": "A prospective study was conducted for the FDA clearance of an ACM and EDA-based CS-detection device based on a predefined machine learning algorithm." }, { "kind": "peer-reviewed study", "citation": "Jahani A, Galindo Lazo DA, Sarzo Wabi I, Gharbi O, Robert M, Millan JP, D'Onofrio G, Robin A, Nguyen DK, Bou Assi E (2026). Prospective evaluation of a seizure detection wearable device for timely interventions in an epilepsy monitoring unit. Epilepsia 67(4):1802-1816 (PMC13075604).", "title": "Prospective evaluation of a seizure detection wearable device for timely interventions in an epilepsy monitoring unit", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/", "date": "2026-01-07", "written_by": "independent", "quote": "Alerts successfully reached caregivers in 15 of 16 cases, with one failure due to a Wi‐Fi disconnection." } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "evidence" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sources[].id": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "AIBD-0296-source-0001", "AIBD-0296-source-0002", "AIBD-0296-source-0003", "AIBD-0296-source-0004", "AIBD-0296-source-0005" ], "role": "Existing evidence items, in their original order" }, "provenance": { "kind": "curatorial", "basis": "Stable within the fingerprinted record version; no source content or source review has been added.", "record_fields": [], "source_refs": [] }, "review_state": "record_mapped", "coverage": "complete" }, "sources[].language": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "sources[].relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "news report", "citation": "Dolgin E (2018). 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Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit. Frontiers in Neurology 12:724904 (PMC8418082). Lead authors at Empatica, Inc.", "title": "Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/", "date": "2021-08-18", "written_by": "makers", "quote": "A prospective study was conducted for the FDA clearance of an ACM and EDA-based CS-detection device based on a predefined machine learning algorithm." }, { "kind": "peer-reviewed study", "citation": "Jahani A, Galindo Lazo DA, Sarzo Wabi I, Gharbi O, Robert M, Millan JP, D'Onofrio G, Robin A, Nguyen DK, Bou Assi E (2026). Prospective evaluation of a seizure detection wearable device for timely interventions in an epilepsy monitoring unit. Epilepsia 67(4):1802-1816 (PMC13075604).", "title": "Prospective evaluation of a seizure detection wearable device for timely interventions in an epilepsy monitoring unit", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/", "date": "2026-01-07", "written_by": "independent", "quote": "Alerts successfully reached caregivers in 15 of 16 cases, with one failure due to a Wi‐Fi disconnection." } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "evidence" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sources[].upstream_sources": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "strategic_assessments[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "strategic assessments" }, "summary": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "summary": "IEEE Spectrum (6 February 2018): an Embrace wristband alerted the mother of Morgan McGrath, 26, of Fulton, Mo., during a seizure about 15 months earlier; she called paramedics and McGrath survived.", "account": "Elie Dolgin reported in IEEE Spectrum on 6 February 2018 on Morgan McGrath, a 26-year-old teacher from Fulton, Missouri. She “suffered an epileptic seizure that left her unresponsive, frothing at the mouth, with blue lips, and not breathing”. The article dates the seizure to “fifteen months ago”, about November 2016. Her wrist-worn Embrace device alerted her mother, who called the paramedics, and “thanks to a timely response, McGrath is alive and well today”. The article says it records skin conductance and three-axis accelerometer data and “uses a proprietary algorithm to signal when someone is having a convulsive seizure”. The app sends a text or call to pre-specified caregivers. In testing on 135 patients over more than 6,500 hours it “correctly identified nearly every single seizure”. The Food and Drug Administration (FDA) cleared Embrace (Empatica S.r.l.) under 510(k) K172935 on 26 January 2018, after the McGrath event. The 510(k) summary describes an on-board algorithm validated against video electroencephalography (EEG). On detecting a likely generalized tonic-clonic seizure, it messages the Alert app to call and text designated caregivers. A later prospective multicenter study (Onorati et al. 2021) by Empatica staff with hospital co-authors reports sensitivity for a predefined machine-learning algorithm. It was 0.92 in children and 0.94 in adults. An independent Montreal epilepsy-monitoring-unit study (Jahani et al. 2026) found the Embrace2 detected all 16 convulsive seizures while worn and working. Alerts reached caregivers in 15 of 16 cases, with 29 false alarms. The McGrath rescue rests on this single news item. The Empatica case-study abstract (Regalia, Onorati, Picard, American Epilepsy Society) is not among the sources. 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She “suffered an epileptic seizure that left her unresponsive, frothing at the mouth, with blue lips, and not breathing”. The article dates the seizure to “fifteen months ago”, about November 2016. Her wrist-worn Embrace device alerted her mother, who called the paramedics, and “thanks to a timely response, McGrath is alive and well today”. The article says it records skin conductance and three-axis accelerometer data and “uses a proprietary algorithm to signal when someone is having a convulsive seizure”. The app sends a text or call to pre-specified caregivers. In testing on 135 patients over more than 6,500 hours it “correctly identified nearly every single seizure”. The Food and Drug Administration (FDA) cleared Embrace (Empatica S.r.l.) under 510(k) K172935 on 26 January 2018, after the McGrath event. The 510(k) summary describes an on-board algorithm validated against video electroencephalography (EEG). On detecting a likely generalized tonic-clonic seizure, it messages the Alert app to call and text designated caregivers. A later prospective multicenter study (Onorati et al. 2021) by Empatica staff with hospital co-authors reports sensitivity for a predefined machine-learning algorithm. It was 0.92 in children and 0.94 in adults. An independent Montreal epilepsy-monitoring-unit study (Jahani et al. 2026) found the Embrace2 detected all 16 convulsive seizures while worn and working. Alerts reached caregivers in 15 of 16 cases, with 29 false alarms. The McGrath rescue rests on this single news item. The Empatica case-study abstract (Regalia, Onorati, Picard, American Epilepsy Society) is not among the sources. No second account of the McGrath event was found.", "replication": { "produced_by": [ "A convulsive (generalized tonic-clonic) seizure, the only type the device is cleared to detect", "The wristband worn and paired with a phone running the Alert app, with a caregiver designated", "A caregiver able to reach the patient or call emergency services on receiving the alert" ], "must_hold": [ "Connectivity between watch, phone and caregiver (one of 16 alerts in Montreal failed on a Wi-Fi disconnection)", "Caregivers tolerate false alarms (29 in 373 monitoring days in Montreal, mostly from routine movements)", "Focal seizures without convulsions are not detected (none of 510 in Montreal)" ], "echoes": [ { "date": "2026-01-07", "setting": "Center hospitalier de l'Université de Montréal epilepsy monitoring unit, 72 patients, April 2024 to June 2025; alerts routed to nursing staff", "model_version": "Embrace2", "outcome": "recurred", "source": "Jahani et al. (2026) Epilepsia 67(4):1802-1816, https://pmc.ncbi.nlm.nih.gov/articles/PMC13075604/ (quote: 'The Embrace2 wrist‐worn device detected all 16 FBTCSs/GTCSs that occurred while the device was functioning and worn, but none of 510 FSs.')" }, { "date": "2021-08-18", "setting": "Multicentre epilepsy-monitoring-unit study, 152 patients (85 children), 66 convulsive seizures; detection performance only, no home alerts", "outcome": "recurred", "source": "Onorati et al. (2021) Front Neurol 12:724904, https://pmc.ncbi.nlm.nih.gov/articles/PMC8418082/ (sensitivity 0.92 pediatric, 0.94 adult; false alarm rate 1.26 and 0.57 per 24 h)" } ] } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "account", "replication" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" } }, "summary": { "total": 91, "addressed": 91, "known": 32, "reviewed": 0, "record_mapped": 32, "not_assessed": 59, "complete": false, "by_state": { "value_present": 32, "not_reported": 0, "unresolved": 0, "not_assessed": 59, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }