The latest news on Ketryx

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.

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.

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...

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...

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

During the 2022 Spring Meeting, the following startups affiliated with the Media Lab will be presenting (hosted by the E14 Fund)

BIOMEDevice Silicon Valley, the must-attend regional show connecting engineers and cutting-edge medtech companies, today announces registration is now live for November.

MIT Startup Exchange Lightning Talk by Erez Kaminski, Founder and CEO, Ketryx on End-to-end regulated software development platform

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...

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

Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulti...

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.

Quality and operations should focus on eliminating friction from their decision-making process by transitioning clerical tasks humans perform to computers.