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Live Webinar December 13th: Postmarket Surveillance of AI Systems
In the News
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications
QA / RA
Dev / R&D
The latest news on Ketryx
Get to know the latest stories from and about Ketryx.
In the News
Preparing for the PATCH Act and RTA
The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.
The PATCH Act’s approach to securing medical devices actually gives malicious actors a blueprint
Former head of the FDA software engineering lab Paul Jones writes on the complications of securing medical devices in the wake of the PATCH Act.
November 7, 2023
The Transformative Impact of Patient Apps in Healthcare
COVID has opened the floodgates and allowed the ecosystem to evolve rapidly. A lot of the recent acceleration has to do with the reimbursement of services. We have had...
August 9, 2021
GxP AI Workflow: An NLP Case Study
In this second AI Learning Session covering the topics most frequently requested by our AI Experts Network, Erez Kaminski provides an overview of a systematic way to de...
December 3, 2021
What Makes a Company Successful at Using AI?
Companies in a wide range of industries are trying to integrate analytics and data to improve their operations, with decidedly mixed results. What are top performers doing
February 28, 2022
MIT Media Lab Spring Meeting 2022: E14 Startups
During the 2022 Spring Meeting, the following startups affiliated with the Media Lab will be presenting (hosted by the E14 Fund)
April 6, 2022
Keynote Speakers from Medtronic and Ketryx Corporation Taking the Stage at BIOMEDevice Silicon Valley
BIOMEDevice Silicon Valley, the must-attend regional show connecting engineers and cutting-edge medtech companies, today announces registration is now live for November.
October 25, 2022
2022 MIT Research and Development Conference
MIT Startup Exchange Lightning Talk by Erez Kaminski, Founder and CEO, Ketryx on End-to-end regulated software development platform
November 15, 2022
The Future of Healthcare Is Connected & Data-Driven
The opening keynote for BIOMEDevice Silicon Valley was well-attended and the topic was indeed a concerning – Developing Cloud-Based Software in a Changing Regulator...
November 30, 2022
Best Practices When building AI-based Medical Devices at Scale
An inherent part of building data-driven software is the constant need for change, but existing lifecycle management tools and processes for medical systems create signifi
March 31, 2023
How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity
Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulti...
May 10, 2023
How to Build Safer and More Reliable Software
Innovative software continues to disrupt society as we know it, including solving big problems, squeezing out new efficiencies and creating a better quality of life.
June 1, 2023
Solving the Systems Interconnectivity Problem
Quality and operations should focus on eliminating friction from their decision-making process by transitioning clerical tasks humans perform to computers.
June 1, 2023
Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners
Investment fuels innovation to ensure patient safety and validate the use of AI in medical devices
December 5, 2023
Ketryx Unveils the First Connected Lifecycle Software for MedTechs
Bringing FDA-approved, life-saving innovations to patients 3x faster
May 16, 2023
Discover a new way to develop
Creating and managing the lifecycle of a medical application is expensive, time-consuming, and error-prone. But what if it didn't need to be?