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Description

Cruxi is a specialized vertical AI platform designed for teams involved in the regulatory processes of medical devices. It efficiently processes a variety of sources, including FDA regulations, guidance documents, product codes, standards, MAUDE events, recalls, and historical 510(k) submissions to enhance workflows related to 510(k), De Novo, and eSTAR applications. Users benefit from the ability to quickly classify devices, analyze predicates, strategize evidence presentation, and create fully referenced content that aligns with the requirements of eSTAR for each part of their submission. The platform not only provides comprehensive submission workflows but also offers targeted micro-services, such as classification, predicate evaluation, and drafting of specific sections. This versatility makes Cruxi particularly valuable for early-stage startups, in-house regulatory teams, and consultants, enabling them to produce high-quality submissions while minimizing manual effort and reducing unforeseen challenges with the FDA. By streamlining the regulatory submission process, Cruxi ultimately helps organizations navigate the complexities of compliance more effectively.

Description

We assess health beyond traditional healthcare environments to gain a deeper insight into the burden of diseases. This holistic perspective on patient wellness reveals new business avenues by introducing innovative metrics for understanding disease and patient health. By cultivating a patient-focused comprehension of how diseases affect daily functioning, we can engage both physicians and payers more effectively while enhancing patient support initiatives. Furthermore, we aim to develop sophisticated algorithms that can forecast disease onset and its progression or regression, as well as pinpoint critical moments for intervention. Utilize actual digital data to advocate for the advantages of your offerings. Our technology-driven service facilitates real-world research that integrates unique, day-to-day behavioral information, thereby benefiting clinical, medical affairs, and commercial divisions, all while utilizing Evidation's virtual research site, Achievement. With adaptable study designs, strategies for device integration, and streamlined protocol management, we ensure efficient study operations. Additionally, we offer the flexibility for sponsorship either by us or your organization, allowing for tailored collaboration.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Jupyter Notebook No 
Lumos No 
R-Studio No 

Integrations

Jupyter Notebook Yes 
Lumos Yes 
R-Studio Yes 

Pricing Details

Credit-based system
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Cruxi

Founded

2024

Country

United States

Website

cruxi.ai

Vendor Details

Company Name

Evidation

Founded

2012

Country

United States

Website

evidation.com/solutions/

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