--- title: "CRM, Cardiac Rhythm Management | MedTech Terms" description: "Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cardiac-rhythm-management#term", "name": "Cardiac Rhythm Management", "alternateName": [ "CRM", "CRM devices", "Cardiac electronic implantable devices", "CIEDs" ], "description": "Cardiac Rhythm Management (CRM) is the MedTech segment that develops devices for diagnosing and treating bradyarrhythmias, tachyarrhythmias, and heart failure conduction disorders. The category covers permanent pacemakers (single, dual, leadless), implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT-P, CRT-D), insertable cardiac monitors (ICMs), and the leads, programmers, and remote-monitoring infrastructure that surround them. 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FDA has issued device-specific guidance for them." } }, { "@type": "Question", "name": "Is remote monitoring of CRM devices reimbursed?", "acceptedAnswer": { "@type": "Answer", "text": "Yes. CPT 93294, 93295, 93296, 93297, and 93298 cover remote interrogation and technical/professional components for pacemakers, ICDs, and ICMs." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Cardiac Rhythm Management [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape)CRM # Cardiac Rhythm Management Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition Cardiac Rhythm Management (CRM) is the MedTech segment that develops devices for diagnosing and treating bradyarrhythmias, tachyarrhythmias, and heart failure conduction disorders. The category covers permanent pacemakers (single, dual, leadless), implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT-P, CRT-D), insertable cardiac monitors (ICMs), and the leads, programmers, and remote-monitoring infrastructure that surround them. CRM devices are almost exclusively Class III in the US ( [PMA](/terms/pma) pathway) because they support or sustain life, and almost all modern CRM systems include wireless telemetry that places them squarely under FDA's Section [524B](/terms/section-524b) cyber device authority. What the regulation says Most CRM devices follow [PMA](/terms/pma) (21 CFR 814) and are governed by FDA-recognized consensus standards including ISO 14708-1/-2/-6 (active implantable medical devices) and IEC 60601-2-31. ICDs and pacemakers are subject to dedicated FDA guidance on premarket submissions and to mandatory [MDR](/terms/mdr-reporting) reporting under 21 CFR Part 803. Connected CRM systems are cyber devices under [Section 524B of the FD&C Act](/terms/section-524b) and must include a [SBOM](/terms/sbom), vulnerability monitoring plan, and coordinated disclosure process. ## What this means in practice CRM is one of the highest-revenue MedTech segments and a leading source of post-market cybersecurity advisories (Medtronic CareLink/Conexus, St. Jude Merlin@home). Market dynamics are shaped by leadless pacing, extravascular ICDs, conduction-system pacing, and remote-monitoring reimbursement ( [CPT](/terms/cpt-codes) 93294-93298). Common pitfalls - • Treating CRM telemetry links as a closed system, they are cyber-device interfaces under 524B. - • Underestimating the regulatory burden of lead changes, which often require a PMA supplement. - • Ignoring remote-monitoring reimbursement codes that materially shape product economics. ## Frequently asked questions Are leadless pacemakers a separate FDA category? They go through [PMA](/terms/pma) like traditional pacemakers but are reviewed under their own product codes (e.g., NVZ for leadless single-chamber). FDA has issued device-specific guidance for them. Is remote monitoring of CRM devices reimbursed? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Electrophysiology(EP) Diagnosis and catheter-based treatment of cardiac arrhythmias. ](/terms/electrophysiology)[ Market Segments Neuromodulation Implantable devices that stimulate the nervous system to treat disease. ](/terms/neuromodulation)[ Market Segments Structural Heart Transcatheter therapies for valvular and structural heart disease. ](/terms/structural-heart)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular)[ Market Segments Clinical Laboratory Improvement Amendments(CLIA) U.S. federal standards that govern clinical laboratory testing. ](/terms/clia) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 ISO· 1 HRS· 1 1. [1 FDA, Pacemakers Verified FDA · fda.gov ](https://www.fda.gov/consumers/consumer-updates/fda-approved-devices-help-keep-heart-beating) 2. [2 ISO 14708-2 Active implantable medical devices, Pacemakers Verified ISO · iso.org ](https://www.iso.org/standard/74057.html) 3. [3 Heart Rhythm Society Remote Monitoring Consensus Verified HRS · hrsonline.org ](https://www.hrsonline.org/guidance/clinical-resources/2015-hrs-expert-consensus-statement-remote-interrogation-and-monitoring-cardiovascular-electronic) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Acronym CRM Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=cardiac-rhythm-management) Learn in 60 seconds Card Lesson Quiz Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. - · CRM is one of the highest-revenue MedTech segments and a leading source of post-market cybersecurity advisories (Medtronic CareLink/Conexus, St. - · Jude Merlin@home). - · Market dynamics are shaped by leadless pacing, extravascular ICDs, conduction-system pacing, and remote-monitoring reimbursement (CPT 93294-93298). Remember this Watch out: Treating CRM telemetry links as a closed system, they are cyber-device interfaces under 524B. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Structural Heart ](/terms/structural-heart) - [Electrophysiology(EP) ](/terms/electrophysiology) - [Neuromodulation ](/terms/neuromodulation) You may also need Auto-suggested from Market Segments and shared keywords. - [Cardiovascular Devices ](/terms/cardiovascular) - [Urology Devices ](/terms/urology-devices) - [Hearing Devices ](/terms/hearing-devices) - [Patient Monitoring ](/terms/patient-monitoring) - [Brainjacking ](/terms/brainjacking) - [Class III Device ](/terms/class-iii) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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