Transform Raw Procedural Data into Clinical Certainty

Revolutionize your device projects and fast-track results with real-world data from robust clinical registries

The Registry Data Difference

Procedures captured across Fivos registries.

Total costs saved in six industry studies that used registry data.

Reduction in time to acquire data for label expansion with reliance on clinical registries.

Tailored Evidence, Empowered Success

Reliable real-world data offers critical insights for identifying and fostering advancements and device performance as regulations and clinical practices change. Go beyond traditional claims and clinical EMR details; rely on Fivos’ tailored data solutions to access data for diverse industry needs.

With over a decade of experience partnering with device companies, Fivos has developed robust data linking approaches and collaborate closely with the FDA. Rely on our licensed data and comprehensive reports to meet stringent requirements for submissions to regulatory bodies, strengthen industry, compliance and innovation, and pivot quickly when global compliance standards shift.

Total Product Lifestyle Data Solutions

From aggregate reports utilizing existing registry data to exclusive data projects that solve your most complex evidence gaps, Fivos delivers accelerated insights to move your projects forward.

Registry data captures all procedural data – whether on label or outside of the approved indication.

Manufacturers must prepare PSUR (patient safety update reports) annually for Class IIb and III devices.

Provides propensity-matched control patients for new device comparison (2:1).

Facilitate conditional approval requirements (PMA or 510(k)).

The best-performing centers with relevant experience and patient population are chosen.

Compiled data and analysis submitted to CMS as part of their application.

Industry Portfolio

Fivos Data Partners

Registry Data in Action

We capture, package, and deliver a wealth of granular device and procedural-level data, with proven results across the spectrum. Here’s a look at some of our most recent projects…

End-to-End Product Lifecycle

Custom data processing and analysis utilizing fully de-identified aggregate device data collected for purposes of label expansion. Entailed full-service support—from aggregate reports to pre-submission consulting and regulatory submission.

Long-term Surveillance

The first and only FDA-approved registry-based surveillance protocol for the complete evaluation of long-term outcomes 10 years after Endovascular Aneurysm Repair (EVAR).

External Control Arm

A collaboration to develop a prospectively designed RWE evaluation of FAST II data using a propensity-matched registry comparator, resulting in FAST II and control cohorts well matched for key clinical variables.

Dive Deep Into Your Device Data

Gain unprecedented insights with Fivos’ Device Evaluation Portal (DEP), offering direct access to real-world, near real-time data from clinical registries. Our flexible tiered membership empowers you to select the depth of data that aligns with your objectives, from device usage snapshots to in-depth analyses of patient demographics and clinical outcomes. The DEP delivers:

In-depth Competitive Analysis
Compare your device performance against market competitors
Regulatory and Market Advancement
Support submissions with robust real-world evidence
Enhanced Outcome Tracking
Monitor device performance across diverse patient populations
Accelerate Innovation
Identify opportunities for product improvement and differentiation

Learn More

Transform Healthcare with Quality Data