Dive Brief:
- Ketryx, a startup that uses artificial intelligence to help medical device companies with documentation and regulatory compliance, raised $39 million in a series B funding round, the company announced Thursday.
- Transformation Capital led the funding round, with partner and founding team member Vinay Shah joining Ketryx’s board. Former Medtronic CEO Bill Hawkins also joined as a new investor.
- Ketryx’s platform includes tools to help with building software as a medical device applications and AI in medical devices while remaining compliant. Its customers include three of the five top global medtech companies, and AI firms such as DeepHealth, Heartflow and Aignostics.
Dive Insight:
As the Food and Drug Administration regulates a growing number of software and AI tools, the agency is also clarifying regulatory requirements. For example, the FDA has opened a pathway for pre-determined changes to medical devices — which could be useful for updates to AI models — but the process requires upfront documentation.
Ketryx’s platform is intended to help automate software documentation.
“I’ve spent the last decade at the intersection of AI and life sciences, watching it evolve from an emerging tool to a critical application for patients,” CEO and founder Erez Kaminski said in a statement. “It’s now time to accelerate adoption and ensure AI is safe, reliable, and ready for regulated environments.”
Other investors participating in the funding round include Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures and 53 Stations.
Ketryx said it has raised more than $55 million to date.
