BETA
Developer and commercializer of cardiac data-management software and remote-monitoring solutions.
PaceMate develops and commercializes cardiac data-management software and provides supporting remote-monitoring services. Its portfolio includes the cloud-based PaceMateLIVE platform and the PaceArt business acquired from Medtronic in 2024.
PaceMateLIVE brings cardiac-device information and electronic health record data into clinical workflows. PaceArt originated as a system combining electrocardiography, transtelephonic receiving and device-clinic management functions. Software, support services and device functions have distinct regulatory roles.
This profile covers those two documented software families. The original FDA clearance for Paceart Optima was issued to Medtronic; its scope is not automatically transferred to PaceMateLIVE or every current software version. Current legal-manufacturer responsibility and version coverage require further documentation.
PaceMate announced acquisition of Medtronic’s Paceart Optima system on August 27, 2024. The VA independently identifies PaceMate as vendor and records the 2024 acquisition and rebranding. The current PaceArt page emphasizes migration and ongoing platform integration; current editions and availability should be confirmed directly. [1][4][7]
FDA K110693 describes Paceart Optima software as a pacemaker waveform analyzer and digital electrocardiograph with medical-device data-system functions. Medtronic is the original submitter. This historical evidence supports device lineage but does not establish that PaceMateLIVE, Auto-Triage or every current PaceArt version is FDA-cleared. [8]
PaceMateLIVE is commercially offered alongside clinical support and data services. Its software functions need individual regulatory assessment; security certifications, EHR connectivity and clinical use do not independently establish FDA clearance. [5]
Authorization and recall mapping across historical Medtronic names and product versions remains incomplete.
Latest recorded source review: 2026-10-28.
Documented commercial product families.
Cloud platform that consolidates cardiac-device and EHR data for clinical review, patient prioritization and device-clinic workflows. [5]
Marketed · regulatory scope variesListed by the company; configurations and market availability vary.
Acquired software family integrating cardiac-device, programmer and patient data into device-clinic workflows; original system included ECG and transtelephonic receiving functions. [7][8]
Marketed · regulatory scope variesListed by the company; configurations and market availability vary.
PaceMate announced acquisition of the Paceart Optima system from Medtronic. [1]
Accessed 10/29/2026