Kimi’s AI engine extracts and aggregates critical information hidden within documents and databases, empowering your competitive & regulatory strategy, saving hours of painful searching.
Kimi, Māori Dictionary / (verb) (-hia) to look for, seek, search, hunt for
Elevate Your Medical Device Strategy
with Powerful Regulatory and Competitive Insights
Kimi’s AI engine extracts and aggregates critical information hidden within FDA documents and databases, saving hours of painful searching.
Find what you need quickly, without reviewing multiple documents and databases
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.
Eylam Oron
Senior Product Manager Lead
"Kimi saves me time. Pure and simple. I started using Kimi for competitive analyses and there’s no going back to our previous (tedious) way of working."
Gayathri Sumesh Nair
Senior Manager, RA/QA
“I have experienced how easy predicate search can be by searching through Kimi! Absolutely loved it."
Ilya Divinsky
R&D Executive
“My initial experience with Kimi was absolutely fantastic and then got better when I discovered the Predicate Tree! As an R&D Manager who likes to be well informed about the regulatory landscape of our devices, Kimi gives me what I need quickly and easily.”
Simple yet powerful tools to gain insights
... while saving time
Intuitive free text search
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Search for terms used in 510K summary documents, using natural language.
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Kimi’s AI engine will search for your specified terms in various sections of all available 510K summary documents (including: Indications for Use, Device Descriptions, Intended Use).
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Allows you to start searching before you have identified a relevant FDA product code.
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Enables broader searches and more results feeding your regulatory or competitive analysis.
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 .
Customizable email notifications
Get notified immediately when new medical devices are cleared/approved, matching your criteria of interest, such as:
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Indications for use terms
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Intended use terms
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Device description terms
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FDA product codes
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Predicate device
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Company name
NEW: Get 510(k) Summary Letters directly to your mail box as they become available!
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.
I really like using Kimi, I use it mainly for due diligence of a company or a concept, and when I want to get a quick understanding of a company’s regulatory strategy. The predicate tree is VERY useful when I need to present my results. Kimi is very easy to use and super helpful.
Gal Atarot
Chief Technology Officer
MEDX Xelerator (health-focused incubator)
My initial experience with Kimi was absolutely fantastic and then got better when I discovered the Predicate Tree! As an R&D Manager who likes to be informed about the regulatory landscape of our devices, Kimi gives me what I need quickly and easily.
Ilya Divinsky
R&D Executive and consultant
Questions that KIMI helps you answer
What are the relevant predicates for my new device?
What is the relevant FDA product code for my device?
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What other devices are FDA cleared / approved for the same indication?
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Who are my competitors?
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What other devices use the same technology, for different indications?
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What intended use and indications for use claims are similar devices making?
Identify the regulatory & competitive landscape of your device quickly and efficiently
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.
Who is KIMI for?
Product Experts
Spend less time searching for competitors, device claims, FDA product codes and similar devices.
R&D Managers and Project Managers
Easily educate your development team about the competitive & regulatory landscape of your device.
Regulatory Affairs Experts & Consultants
Quickly and easily identifies potential predicates, product codes, indications for use statements, and more.
Medical Device
Start-Up Founders
Quickly and easily identify possible device claims, FDA product codes, similar devices, and potential competitors.
Clinical Affairs Experts
Spend less time searching for similar devices, device claims, and related clinical trials*
*coming soon, stay tuned!
Venture Capitalists & Investors
Get a quick understanding of the medical device innovation landscape in your relevant domains.
Marketing Experts
Quickly and easily identify the competitive landscape of your device.
Incubators
Get a quick understanding of the medical device innovation landscape in your relevant domains.