Smarter Open Data, Better MedTech Decisions

We help MedTech companies to accelerate their road to US clearance and sales. We provide regulatory and reimbursement data from the FDA, Medicare, and other government agencies.

Our data

Free Regulatory and Reimbursement Report for MedTech Companies Targeting the US

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Reimbursement codes

Explore our comprehensive collection of HCPCS codes, APC codes, and DRG codes, used for accurately reporting standardize medical billing. 

Clinical Trial Flavicon

60,000 Clinical Trial PDFs

 We wrote custom code to acquire and process Protocols, Statistical Analysis Plans (“SAPs”) and Informed Consent Forms (“ICFs”) from ClinicalTrials.gov

FDA cleared 510 ks

92,000 FDA Medical devices 510k PDFs

From the FDA’s website we acquired and processed approval documents for medical devices called “510(k)s” with over 92,000 individual PDFs with 660,000 unique pages.

PMA approved data from the FDA

2,500 FDA Medical devices PMA PDFs

The FDA has a second path to medical device approvals, called “PMAs”. We acquired and processed those approval documents with over 75,000 unique pages.

MedTech tracker complete airport concept

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MedTech Tracker: The Airport to MedTech Success

MedTech Tracker operates like a world-class airport, ensuring that MedTech companies transition smoothly from innovation to market success. Just as an airport consists of interconnected components that guide passengers to their destinations, we provide structured pathways to help companies navigate regulatory approvals, technical development, marketing, funding, and post-market strategies.

Terminal Building: Regulatory Pathway

Just as a terminal building is where every journey begins, our Regulatory Pathway serves as the starting point for MedTech companies, guiding them through the approval process. We help you choose the right regulatory route, whether 510(k), PMA, or another pathway, ensuring compliance with FDA regulations and market-specific requirements. Additionally, we provide insights into market size and reimbursement volume, helping you identify the most profitable markets for your medical device.

Parking Lot: The Different Roles

Before stepping into the airport, every traveler first arrives at the parking lot, where various passengers head for different destinations. This represents the many key players in the MedTech industry, including founders, technical leads, regulatory specialists, marketers, patient/provider support teams, investors, venture capitalists, and accelerators. Each role plays a crucial part in supporting a company’s journey.

Control Tower: MedTech Tracker

At the heart of every successful airport is the control tower, which ensures the safe and efficient movement of flights. MedTech Tracker functions as the control tower, overseeing the entire MedTech journey and providing crucial guidance at every stage. By supplying regulatory and reimbursement data from the FDA, Medicare, and other government agencies, we help companies stay on course and avoid unnecessary delays.

Hangar: Technical Pathway

The hangar is where aircraft are built, maintained, repaired, and prepared for flight—just like the Technical Pathway at MedTech Tracker. This pathway focuses on product development, compliance, and technological advancements, ensuring that MedTech innovations are properly designed, tested, and ready for regulatory clearance and commercialization.

Apron: Marketing Pathway

Before takeoff, aircraft are positioned on the apron, where they are refueled, loaded with passengers and cargo, and prepped for departure. This mirrors our Marketing Pathway, which helps companies build strong market strategies, create brand awareness, and position their products effectively to reach their target audience.

Taxiway/Approach Runway: Post-Marketing Pathway

After landing, aircraft move along the taxiway toward the terminal or other designated locations. Similarly, our Post-Marketing Pathway ensures that MedTech products remain compliant, continuously improve, and adapt to new regulations and market needs after entering the market. This pathway helps companies maintain momentum, address customer feedback, and optimize their long-term success.

Runway: Secure Funding Pathway

A runway is the final stretch needed for an aircraft to achieve takeoff. Similarly, the Secure Funding Pathway helps MedTech companies to secure the financial resources required to launch their innovations successfully.

Gas Tanks:

Just like gas tanks store fuel to power planes for takeoff, investor funding fuels MedTech companies, enabling them to scale, innovate, and succeed in a competitive market.

MedTech Reference Guide

MedTech Reference Guide

Gain a better understanding of your product code, access essential medicare data and reimbursement codes. Download the MedTech Reference Guide today and request your free Regulatory and Reimbursement Report to stay ahead in the industry.

Our mission:

Our mission is to help MedTech Startups to scale faster and accelerate their road to US clearance and sales by providing regulatory and reimbursement data from the FDA, Medicare, and other government agencies. We are dedicated to empowering founders, technical lead, regulatory, marketers, patient/provider support, Investor/VC and Accelerators ensuring they have the tools to succeed and make a meaningful impact on healthcare.

Why choose us?

We are committed and passionate about transforming data into actionable insights. Our team is small, agile, and fast, allowing us to deliver customized solutions that cater to your specific needs. With our innovative approach, we empower you to confidently navigate the complexities of the MedTech landscape.

Our Product and Services

We provide regulatory and reimbursement data from the FDA, Medicare, and other government agencies that is specific to your desired product codes. We offer a free Consultation to our clients that enable us ensure they get the Go to market strategy to succeed in  the MedTech Landscape. Our dedicated team is here to guide you through every step of the process, empowering you with the right open data to enable you make informed decisions that drive growth and innovation in your journey.

Coming soon!

A Business Navigator to guide your MedTech Company

An intelligent business management tool designed to give you enhanced visibility into your desired MedTech data. Our platform serves as a Business Navigator, equipping you with interactive charts, graphs, and maps to guide you in making data-driven MedTech decisions with confidence.

Data Visualization for MedTech Open Data

ORTHOSENS

“It also helped me to think for myself and systematize in my head what a technical person really wants.”

Oleg

Technical Lead

ORTHOSENS

“As a technical person, having access to data like indications for use, device descriptions, electrical information, and instructions for use in the PMA document is invaluable. It will directly impact my production and manufacturing processes.”

Oleg

Technical Lead

ORTHOSENS

“As a MedTech founder, I needed a clear guide to navigate the complex landscape. One session with MedTech Tracker gave me a solid go-to-market strategy and access to critical data and reimbursement insights across different US states. A great tool to fast-track your startup development journey.”

Gwenael Hannema

CEO

CNS THERAPY

“Accessing recent data from the last 1-15 years is the most valuable to us, this gives us an understanding of patient challenges, consequences during device use, and the level of intervention which gives us the insights we need to improve our device outcomes”.

Ilaria

CNS THERAPY

“The main issue is lack of time to process all available data and extract what’s truly relevant. This system transforms raw data into consumable information. We have lots of data but very little actual information.”

Marc Mathys

NEUROSOFT

“Knowing Medicare reimbursement rates is crucial, it shapes our pricing strategy and helps us position our products effectively in the US market.”

Nicolas Vachicouras

Founder

SPARK WESTERN SWITZERLAND

“Investors want real market opportunities, not just optimistic claims. Founders need to show realistic market size, the competitor landscape, and reimbursement insights on who’s paying, how much, and whether the product is financially viable.”

Kelly Carrol

Investor

SWISS MEDICAL CONSULTANTS

“This system can address some of the biggest challenges in MedTech, which is identifying the right product codes, understanding the mode of action, and finding the best regulatory match. This is crucial in the early stages of product development.”

Philippe D. Etter

LYMPHATICA MEDTECH

“Our product code doesn’t have existing data, so we need to start from scratch. But having access to similar product codes can provide critical insights for us. Also, we can identify patient recruitment sites from the Medicare data about high prescribers.”

Valentina Triacca

Co-founder

 

 

Built For Founders, Technical leads, Regulatory, Marketers, Investors/VC, and Accelerators. 

Our system offers personalized, guided pathways for each role in a MedTech company

Roles Challenges How We Help
Founders • Struggles to extend financial runway
•Always pitching to investors
•Too focused on science, making it hard to communicate business value
• Provides an overview of the project across all key areas
• Supplies data for stronger investor presentations
Technical Leads • Strong technical skills but little to no experience in MedTech regulations • Offers a "guided tour" of MedTech-specific technical requirements
Regulatory Specialists • Needs to review large amounts of data for regulatory submissions
• Responsible for both pre-submission and post-approval compliance
• Summarizes key regulatory data, including adverse event reports
• Provides access to previous filings for reference
• Supplies full texts of 510(k) and PMA approvals
Marketers • Struggles to understand market trends
• Needs a strong go-to-market (GTM) strategy
• Provides reimbursement data at national, state, and provider levels
• Connects with key opinion leaders (KOLs)
Patient/Provider Support • Needs clear documentation to educate users on proper device usage • Provides access to previous Instructions for Use from top companies
Investors / VC • Receives too many investment requests
• Finds it hard to assess which startups have real potential
• Provides an unbiased view of the actual market size
• Compares performance with larger players
• Offers a "reality check" on startup claims
Accelerators • Needs to offer valuable services to members • Delivers customized reports and expert guidance for each company

Personalized consulting

Customized output files

Go-to-market strategy

Reimbursement data

Market size Analysis

FDA Regulations

Secure Data Room

Founders' pitch slides