Keep your heart connected to your medical team without leaving home.

1. 1IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a solely means of diagnosis. It is offered to healthcare providers/professionals on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Class I, according to Medical Device Directive 93/42/EEC. See the instructions for use for more information.
2. 2IM007: 2021. ILR ECG ANALYZER created by Implicity is intended to be used by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. ILR ECG ANALYZER supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the ILR ECG ANALYZER only supports ECG data from Medtronic ICMs. ILR ECG ANALYZER is intended to be electronically interfaced with other computer systems (remote monitoring platforms) that supply the ECG data to ILR ECG ANALYZER and receive the output of ILR ECG ANALYZER (analysis) for viewing by healthcare professionals. ILR ECG ANALYZER provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifacts. ILR ECG ANALYZER is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. ILR ECG ANALYZER interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. ILR ECG ANALYZER is interfaced with the compatible remote monitoring platform from which it receives compatible ICM data file input (Medtronic LNQ11 Medtronic REVEAL XT 9529 Medtronic REVEAL DX 9528) and to which it transmits the output. Read carefully all instructions before use. Results: sensitivity: 98.64 % (509/516), false positive rate: 24.03 % (68/283). FDA cleared Class II medical device and CE marked Class I medical device (under medical device directive 93/42).
   
   SignalHF FDA cleared Class II medical device and CE marked Class IIa (under MDR) medical device. Manufacturer: Implicity. The SignalHF System is intended for use by qualified healthcare professionals (HCP) managing patients over 18 years old who are receiving physiological monitoring for Heart Failure surveillance and implanted with a compatible Cardiac Implantable Electronic Devices (CIED) (i.e., compatible pacemakers, ICDs, and CRTs). The SignalHF System provides additive information to use in conjunction with standard clinical evaluation. The SignalHF HF Score is intended to calculate the risk of HF for a patient in the next 30 days. This System is intended for adjunctive use with other physiological vital signs and patient symptoms and information and is not intended to independently direct therapy.
   
   See the instructions for use for more information.
3. 3N. Varma et al., “Impact of a universal monitoring system (‘third party’) on outcomes of ICD patients: A nationwide study,” Heart Rhythm, 2024.

Implicity is a clinical decision support platform designed to assist your doctor, not to replace their expertise. Please note that this platform is not intended to treat medical emergencies. In such cases, we advise you to contact your doctor or the appropriate emergency number.