Find the medical device information 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."
David Schreiber
Regulatory Specialist,
Hogan-Lovells
“I now use Kimi every time I conduct a regulatory analysis. I find it to be intuitive, user friendly, and it allows for a quick navigation across the devices I am exploring. ”
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
Search for terms used in 510K summary documents, using natural language.
Allows you to start searching before you have identified a relevant FDA product code.
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).
Enables broader searches and more results feeding your regulatory or competitive analysis.
Kimi automatically creates a visual representation of device lineages showing multiple generations of predicate and descendant devices (the “Predicate Tree”).
Identify new “sibling” devices (sharing the same predicates), which may serve as relevant predicates for your device.
Provides a visual snapshot of your device’s ecosystem.
Easily and quickly identify competitors.
Automatic predicate lineage
Analytics for decision-making
Inform your strategic decisions and project planning using actual data and relevant benchmarks.
Learn about important trends for products similar to yours.
Kimi’s engine analyzes all devices cleared / approved under the same product code to provide you with critical time estimates, so you can plan your project based on actual data.
Leverage clearance-time information as a competitive intelligence tool.
Customizable email notifications
Get notified immediately when new medical devices are cleared or 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
Get 510(k) Summary Letters directly to your mail box as they become available!
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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How long does clearance/approval take for this type of device?
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What other devices use the same technology, for different indications?
What intended use and indications for use claims are similar devices making?
Efrat Shefer, Ph.D.
Mentor & Consultant
Former President of Philips Israel
"Kimi helps me understand the regulatory landscape of a device quickly and easily, without having to sift through many databases and documents. It’s convenient and saves me precious time!"
RA specialist
Global Healthcare Technology Company
“Using Kimi definitely saves time compared to searching FDA database, because I can narrow down the search using keywords. Also, I don't need to open 510k Summary of every single device to filter out because intended use statement is readily available.”
Gal Atarot
Chief Technology Officer
MEDX Xelerator
“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."
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.