Investment fuels innovation to ensure patient safety and validate the use of AI in medical devices 

BOSTON, Dec. 5, 2023 /PRNewswire/ — Ketryx, provider of the first and only connected application lifecycle management software for the life sciences industry, today announced that it has raised $14 Million in Series A funding. The round was led by investor Lightspeed Venture Partners, with participation from existing investors including MIT’s E14 Fund and Ubiquity Ventures, bringing the total funding raised to date to over $18 Million. Lightspeed partner Guru Chahal will join the board. The new funds will be used to accelerate product development and commercial expansion. 

The healthcare industry is embracing software and its promise to improve patient outcomes, including the power of Artificial Intelligence/Machine Learning (AI/ML). As a result, companies are grappling with how to maintain quality assurance and regulatory compliance as more frequent software updates are required and software complexity grows.

“Our mission is to enhance medical software safety and reliability, reducing recalls and improving patient outcomes. Quality assurance is becoming more complex as software and AI rapidly permeate the healthcare industry,” said Ketryx founder and CEO Erez Kaminski. “We’re thrilled to partner with Lightspeed to further our mission, expand access to our platform, and meet the fast-growing market demand.”

Traditional manual approaches to software quality assurance are now inadequate and increasingly prone to human errors that could result in injury or death. The solution is to integrate automation and quality process enforcement into the software development lifecycle and quality processes. This ensures teams follow best practices and proactively empowers them to identify and mitigate risks before they affect performance.

With this objective in mind, Ketryx has assembled a team of experts who understand software development, regulation, and AI/ML. It includes professionals from the FDA, Wolfram Research, creator of the world’s largest AI-knowledge engine; and quality leaders from Amgen, one of the world’s leading biotechnology companies known for its high-quality practices.

In building out its solutions, Ketryx spent years designing products around FDA regulations and quality standards. The result is a purpose-built Connected Lifecycle Management platform that automates and aligns many of the manual tasks and processes, like traceability, required of medical software development and quality teams.

Customers can now automate much of what the industry has traditionally done by hand, including documentation, process enforcement, and traceability. In addition, development teams can refocus their time and use modern DevTools and DevOps practices. This is all possible because Ketryx overlays and transforms development tools into an FDA-compliant single source of truth for the total product lifecycle including automated documentation.

“As software becomes more intrinsic to everything we do as a society, there will be more regulation, especially where software impacts human health and safety,” said Guru Chahal, Lightspeed Partner and Ketryx Board Member. “It is key though that we enable technology companies to be compliant with regulations, without impacting the pace at which they innovate. That’s why Lightspeed is so excited about Ketryx – their platform is uniquely positioned to help companies around the world develop software faster while remaining safe and compliant.”

Ketryx is helping some of the top medical device manufacturers in the world streamline their regulated development processes to deliver safer software faster for connected medical devices, drug delivery systems, surgical robotics, imaging diagnostics, and regulated medical apps like digital therapeutics.

Ketryx uses its own software to build and release FDA-compliant cloud-based validated software regularly—the promise that has attracted so many early customers.

About Ketryx
Ketryx is the first and only connected application lifecycle management software for the life sciences industry. Our automation-based software enables companies building FDA-regulated software and AI-based applications to accelerate development through modern cloud-based tools while improving quality and compliance. Ketryx creates a real-time, and traceable, single source of truth by overlaying product development tools and connecting all items, risks, code, and tests. Teams reduce their time to market with automated documentation and improve their quality and compliance through the enforcement of SOPs across connected systems. Learn more at ketryx.com.

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SOURCE Ketryx