FDA Med Device Launch Consultant
Get instant insights on CFR Title 21 regulations, market size, and competitive landscape.
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Business Development & Marketing Teams
Get regulatory, reimbursement, and market insights for your medical device launch.
Market Analysts & Investors
Identify key KOLs and practicing physicians who shape market trends.Pre-Launch Summary
Device Name: AI Cardiac Monitor
Classification: Class II (Requires 510(k) Clearance)
history Predicate Devices Found
3 Predicate Devices identified with similar intended use:
- Device A (FDA Cleared 2021, 510(k) #K123456)
- Device B (FDA Cleared 2020, 510(k) #K234567)
- Device C (FDA Cleared 2019, 510(k) #K345678)
public KOL & Market Insights
Key Opinion Leaders: Dr. John Smith (Mayo Clinic), Dr. Emily Davis (Cleveland Clinic), Dr. Mark Chen (Johns Hopkins), Dr. Rachel Green (Mass General), Dr. Anthony Rodriguez (Cedars-Sinai)
HCP Market Size: Estimated 1,500 potential doctors in the US.
attach_money Reimbursement Codes
The following reimbursement code(s) are applicable for your product:
CPT Code: 93279 - Implantable Cardiac Monitor Interpretation & Report.
HCPCS Code: C1764 - Cardiac event recorder, implantable.
CPT Code: 93241 - External Cardiac Rhythm Monitoring, 48-Hour Report.
HCPCS Code: E0616 - Implantable Telemetry System for Cardiac Monitoring.
gavel CFR Guidance Reference
The following CFR standards are applicable to your product:
CFR Title 21, Part 870.1025 - Implantable Cardiac Monitor Classification.
CFR Title 21, Part 870.2800 - Medical Telemetry Device Regulations.
CFR Title 21, Part 870.2920 - Transmitters & Receivers for Physiological Signals.
CFR Title 21, Part 870.3605 - Pacing System Analyzer Standards.
CFR Title 21, Part 870.3990 - Arrhythmia Detector and Alarm System.