Kimi, Māori Dictionary / (verb) (-hia) to look for, seek, search, hunt for
MEDICAL DEVICE
REGULATORY AND
COMPETITIVE INTELLIGENCE
AT YOUR FINGERTIPS
Kimi’s AI engine extracts and aggregates critical information hidden within documents and databases, empowering your competitive & regulatory strategy, saving hours of painful searching.
*No credit card required, 14-day free trial
INTRODUCING YOUR GO-TO APP FOR CRITICAL
YET HARD-TO-FIND MEDICAL DEVICE INFORMATION
Predicate & reference devices
Predicate and reference devices are extracted and curated from 510K summary documents, so you don’t need to spend precious time looking for them!
Competitors & similar devices
Based on “descendant” devices, which point at your device as their predicate, as well as “sibling” devices, which share the same predicates as your device.
Device lineage
An automatically generated
“Predicate Tree”, offering a visual representation of device lineage, based on predicates extracted and curated from 510K summary documents.
Indications for use
Indications for Use are extracted from 510K summary documents and made fully searchable using free text, allowing you to search for device by indication or technology.
SIMPLE YET POWERFUL TOOLS TO SAVE TIME
INTUITIVE FREE TEXT SEARCH
Search for terms used in 510K summary documents, using natural language
Kimi’s AI engine will search for your specified terms in various sections of all available 510K summary documents (inlcuding: Indications for Use, Device Descriptions, Intended Use)
Allows you to start searching before you have identified a relevant FDA product code
Enables broader searches and more results feeding your regulatory or competitive analysis
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AUTOMATIC PREDICATE LINEAGE
Kimi automatically creates a visual representation of device lineages showing multiple generations of predicate and descendant devices (the “Predicate Tree”)
Provides a visual snapshot of your device’s ecosystem
Identify new “sibling” devices (sharing the same predicates), which may serve as relevant predicates for your device
Easily and quickly identify competitors
EASY SAVING & EXPORTING
Save devices of interest and add your notes
Organize devices using to custom tags
Easily go back to previously identified devices of interest
Export your findings as a table
Easily integrate your insights from Kimi with your other work
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BE THE FIRST KNOW ABOUT YOUR NEW COMPETITOR
Get notified immediately when new medical devices are cleared/approved, matching your criteria of interest, such as:
Indications for use terms
Intended use terms
Device description terms
FDA product codes
Predicate device
Company name
*No credit card required, 14-day free trial
QUESTIONS THAT KIMI HELPS YOU ANSWER:
What is the relevant FDA product code for my device?
What are the relevant predicates for my new device?
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What other devices use the same technology, for different indications?
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Who are my competitors?
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What other devices are FDA cleared / approved for the same indication?
What intended use and indications for use claims are similar devices making?
WHO IS KIMI FOR?
Medical Device
Product Experts
Spend less time searching for competitors, device claims, FDA product codes and similar devices
Medical Device
R&D Managers and Project Managers
Easily educate your development team about the competitive & regulatory landscape of your device
Medical Device
Regulatory Affairs Experts
Quickly and easily identifies potential predicates, product codes, indications for use statements, and more
Medical Device
Regulatory & Clinical Consultants
Spend less time searching for information and maximize your profits
Medical Device
Clinical Affairs Experts
Spend less time searching for similar devices, device claims, and related clinical trials*
*coming soon, stay tuned!
Medical Device
Venture Capitalists & Investors
Get a quick understanding of the medical device innovation landscape in your relevant domains
Medical Device
Marketing Experts
Quickly and easily identify the competitive landscape of your device
Medical Device
Incubators
Get a quick understanding of the medical device innovation landscape in your relevant domains
FIND WHAT YOU NEED QUICKLY, WITHOUT REVIEWING MULTIPLE DOCUMENTS AND DATABASES
Until now, the process of finding medical device information has been tedious and time consuming. This includes finding FDA product codes, potential predicate devices, indications for use statements, and more. We identified the need to create an efficient solution enabling medical device professionals to find critical device information quickly and easily, thus expediting the go-to-market process.