The latest news on Ketryx

Outdated compliance practices are the real killers of innovation in the medtech industry, preventing patients from getting access to better treatment.

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 VP RA/QA 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.

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

An inherent part of building data-driven software is the constant need for change, but existing lifecycle management tools aren't always built for this reality.

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.

MIT Startup Exchange Lightning Talk by Erez Kaminski, CEO of Ketryx on end-to-end regulated software development platforms.

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

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

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...

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

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...

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...

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