This device just got cleared by the FDA. What your planning team needs before it shows up on the equipment list.
Device: BIOMONITOR IV (471155)
Decision Date: 2026-05-01
Applicant: Biotronik, Inc.
Medical Specialty: Cardiovascular
Pathway: 510(k)
About: An insertable cardiac monitor for long-term detection of atrial fibrillation, bradycardia, tachycardia, pause, and sudden rate drop.
Facility Planning Implications
- Biotronik uses remote monitoring tools that need workflow alignment.
- SmartECG cuts false positives and may reduce review workload.
- MR conditional labeling requires MRI policy checks and manual access.
- Single-use insertion tools require supply and disposal planning.
Compatibility and Integrations
BIOMONITOR IV (471155) is compatible with BIOTRONIK Home Monitoring, CardioMessenger Smart, BIOTRONIK Patient App, ProMRI SystemCheck, and ProMRI Configurator.
FAQ
What is BIOMONITOR IV (471155)?
BIOMONITOR IV is an insertable cardiac monitor from Biotronik for long-term arrhythmia detection. It is indicated to detect atrial fibrillation, bradycardia, sudden rate drop, tachycardia, and pause.
What clinical setting is BIOMONITOR IV (471155) used in?
It is used in cardiac rhythm management and ambulatory arrhythmia monitoring programs. Implantation and follow-up typically involve electrophysiology, cardiology, and remote monitoring teams.
What room or space requirements does BIOMONITOR IV (471155) need?
This cardiac monitor is a small implantable device, so it does not require dedicated installed equipment space. Facilities mainly need clean procedural capacity, storage for sterile single-use insertion components, and follow-up workflow support.
What systems does BIOMONITOR IV (471155) need to integrate with?
Facilities should plan around Biotronik’s remote monitoring ecosystem, including BIOTRONIK Home Monitoring, CardioMessenger Smart, and BIOTRONIK Patient App. MRI workflows should also reference ProMRI SystemCheck and ProMRI Configurator for MR conditional screening.
Sources & image credit: FDA 510(k) Database · BIOTRONIK
AI summary based on official and manufacturer data.