Frequently Asked Questions

MedTech Tracker is a data-driven platform that helps medical device companies sell in the U.S. by providing regulatory and reimbursement data from the FDA and Medicare. We help MedTech firms speed up development and regulatory approvals. For investors and VCs, our data can guide smart investment decisions.

Our platform offers regulatory and Medicare reimbursement data filtered by;

60,000+ Clinical Trial Documents

We developed custom technology to acquire, clean, and process key clinical trial documents from ClinicalTrials.gov—a task that would take months to do manually. Our database includes:

• Protocols – Understand study designs and methodologies.
• Statistical Analysis Plans (SAPs) – Learn how trial data was analyzed.
•  Informed Consent Forms (ICFs) – Get insights into patient agreements and ethical considerations.

Total Records: 60,000+ PDFs | 2.7 Million unique pages

92,000+ FDA 510(k) Approvals

The 510(k) process is the most common FDA approval pathway for medical devices. We extracted and processed 92,000+ official FDA 510(k) approvals, giving you access to:

• Approval history – See which devices were cleared and why.
• Device comparisons – Understand similarities between your product and approved devices.
• Regulatory trends – Identify patterns in successful submissions.

Total Records: 92,000 PDFs | 660,000 unique pages

2,500+ FDA PMA Approvals

For high-risk medical devices, the Premarket Approval (PMA) process is required. We have compiled 2,500+ FDA PMA approval records, which include:

•  Detailed approval reports – Understand the toughest regulatory requirements.
• Clinical evidence summaries – See what data led to approval.
• Device safety & effectiveness insights – Learn what it takes to meet strict FDA standards.

Total Records: 2,500 PDFs | 75,000 unique pages

Medicare Reimbursement Data (APC, DRG, HCPCS)

We provide real-time Medicare reimbursement data, including:

• APC (Ambulatory Payment Classifications) – Understand reimbursement for outpatient procedures.
• DRG (Diagnosis-Related Groups) – Learn how hospitals get paid for in-patient treatments.
• HCPCS (Healthcare Common Procedure Coding System) – Identify codes used for billing your device.

With this data, you can see who is reimbursing similar devices, what procedures are covered, and which hospitals & doctors are leading in device use.

We provide regulatory data to help you;

• Find the right FDA product code for your device
• Track past approvals of similar products
• Understand clinical trial requirements
• Access adverse event reports to improve safety and compliance

Yes! We provide FDA and Medicare data to help you understand:

• Who is paying for similar devices
  Reimbursement trends across
• different procedures
• Top hospitals & doctors prescribing similar products
• Go-to-market strategies for pricing and distribution