C8 Health vs Implicity

openFDA lists three Implicity 510(k) clearances, including K230842 for the SignalHF heart failure risk score and K253463 for the ILR ECG Analyzer. openFDA lists no 510(k) under C8 Health, and the vendor makes no FDA claim.

An electrophysiology clinic running pacemaker and ICD follow-up buys Implicity. The vendor shows Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort logos, calls the platform manufacturer-agnostic and claims 26% lower mortality than conventional remote monitoring. For C8 Health, the vendor describes helping hospitals reduce unwarranted clinical variation, and the customers it names include MetroHealth and UNC Anesthesiology. Its MetroHealth figures come from an internal 2024 study and show ERAS compliance rising from 65% to 88% in five months, reported by the vendor rather than a journal. Implicity's customers run device clinics for implanted heart devices, and C8's work centers on perioperative ERAS, glucose and infection protocols.