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In an open-label study with no control group, patients were treated at 29 US sites from January 2022 to July 2023. FDA reviewers report an inappropriate shock rate of 0.357 per 100 patient-months in 290 evaluable patients, below a goal of 2.0. Nine patients each received one appropriate shock, and eight shocks converted the rhythm. The ninth was not repeated because hospital staff switched to an external defibrillator. No device-related serious adverse events or deaths were reported. Investigators withdrew 7 of 305 patients because of skin reactions. FDA approved the Jewel on 30 April 2025. 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It converted 8 of 9 shockable rhythms with one shock.","account":"Element Science of Redwood City, California, makes the Jewel, an adhesive patch defibrillator for people at risk of sudden cardiac arrest. Patients wear it on the chest for 40 to 90 days or longer. A model built with machine learning reads the ECG and decides whether ventricular tachycardia or fibrillation needs a shock. The wearer can hold off a shock during the alarm. In an open-label study with no control group, patients were treated at 29 US sites from January 2022 to July 2023. FDA reviewers report an inappropriate shock rate of 0.357 per 100 patient-months in 290 evaluable patients, below a goal of 2.0. Nine patients each received one appropriate shock, and eight shocks converted the rhythm. The ninth was not repeated because hospital staff switched to an external defibrillator. No device-related serious adverse events or deaths were reported. Investigators withdrew 7 of 305 patients because of skin reactions. FDA approved the Jewel on 30 April 2025. Outcomes for the eight patients after their shocks are not given."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) with a machine learning VT/VF detection algorithm"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"FDA finds that the Jewel patch defibrillator, with a machine-learned rhythm detector, rarely shocked wrongly and converted 8 of 9 dangerous rhythms","headline":"*Jewel* patch defibrillator ended eight of nine life-threatening rhythms"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["38b8cdebe79532202458b5a313ae6899534871b5ada1b1ab60c8d28fdac83d88"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Element Science of Redwood City, California, makes the Jewel, an adhesive patch defibrillator for people at risk of sudden cardiac arrest. Patients wear it on the chest for 40 to 90 days or longer. A model built with machine learning reads the ECG and decides whether ventricular tachycardia or fibrillation needs a shock. The wearer can hold off a shock during the alarm. In an open-label study with no control group, patients were treated at 29 US sites from January 2022 to July 2023. FDA reviewers report an inappropriate shock rate of 0.357 per 100 patient-months in 290 evaluable patients, below a goal of 2.0. Nine patients each received one appropriate shock, and eight shocks converted the rhythm. The ninth was not repeated because hospital staff switched to an external defibrillator. No device-related serious adverse events or deaths were reported. Investigators withdrew 7 of 305 patients because of skin reactions. FDA approved the Jewel on 30 April 2025. Outcomes for the eight patients after their shocks are not given.","replication":{"produced_by":["Patients wore the patch for an average of 21.3 hours a day and replaced the patches every eight days or sooner.","The detector classified segments of ECG and started an alarm after several shockable segments in a row."],"must_hold":["The patient is 18 or older, at risk of sudden cardiac arrest and without an active implantable defibrillator.","The patient keeps wearing the device through the prescribed period."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"661a3521509c03f68959012c286681811255f20b38a468a74ba715ec55dc0d54"}