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What is Evidation Health?

We explore health beyond conventional medical settings to better understand the impact of diseases on individuals. This comprehensive view of patient health uncovers new opportunities for business by introducing innovative ways to measure disease and overall wellness. By focusing on how illnesses influence everyday life, we can improve engagement with both healthcare providers and insurance payers, while also enhancing support for patients. Our goal is to create advanced algorithms that can predict the onset and progression of diseases, as well as identify key moments for timely interventions. Leveraging real digital data, we promote the benefits of our services. Our technology-enabled platform supports real-world research that incorporates unique behavioral data from daily life, offering advantages to clinical, medical affairs, and commercial sectors through Evidation's virtual research hub, Achievement. With customizable study designs and strategies for device integration, we streamline protocol management to ensure effective study execution. Moreover, we provide the option for sponsorship by either our team or your organization, fostering collaborative efforts tailored to specific needs. Ultimately, this approach aims to enhance the overall healthcare landscape by integrating innovative methodologies that benefit all involved stakeholders.

What is Cruxi?

Cruxi is a dedicated vertical AI platform tailored for teams engaged in the regulatory landscape of medical devices. It adeptly handles a range of resources, such as FDA regulations, guidance documents, product codes, standards, MAUDE events, recalls, and historical 510(k) submissions, to optimize workflows associated with 510(k), De Novo, and eSTAR applications. Users gain the advantage of swiftly classifying devices, assessing predicates, formulating evidence strategies, and creating thoroughly referenced content that meets eSTAR requirements for every component of their submission. The platform not only facilitates comprehensive submission workflows but also includes specialized micro-services like classification, predicate analysis, and drafting particular sections. This adaptability renders Cruxi especially beneficial for early-stage startups, internal regulatory teams, and consultants, allowing them to generate high-quality submissions while significantly reducing manual labor and minimizing unexpected issues with the FDA. By simplifying the regulatory submission journey, Cruxi ultimately assists organizations in effectively navigating the intricate landscape of compliance and ensuring timely market access for their devices. Consequently, this leads to improved efficiency and increased confidence in regulatory processes.

Media

Media

Integrations Supported

Jupyter Notebook
Lumos
R-Studio

Integrations Supported

Jupyter Notebook
Lumos
R-Studio

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Credit-based system
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Evidation

Date Founded

2012

Company Location

United States

Company Website

evidation.com/solutions/

Company Facts

Organization Name

Cruxi

Date Founded

2024

Company Location

United States

Company Website

cruxi.ai

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