The Fivos Workflow Solutions have been acquired by Picis Clinical Solutions, Inc. The new business will operate under the original Medstreaming brand.
A new website will be operational in the near future. For now, inquiries may be sent to medstreaming@picis.com.
Revolutionize your device projects and fast-track results with real-world data from clinical registries.
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.
Reliable real-world data offers critical insights for identifying opportunities and fostering advancements in device performance as regulations and clinical practices change. Rely on Fivos’ tailored data solutions to seamlessly access data for diverse industry needs.
Manufacturers must prepare PSUR (patient safety update reports) annually for Class IIb and III devices
Registry data captures all procedural data – whether on label or outside of the approved indication
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
We capture, package, and deliver a wealth of granular device and procedural-level data, with proven results across the spectrum. See what we can do for you.
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.
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).
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.
Endovascular Today summary
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:
