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Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance

Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.
MedCity News
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December 5, 2023
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The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower.

The startup, named Ketryx, announced the close of a $14 million Series A funding round on Tuesday. The round, which brings the company’s total funding amount to $18 million, was led by Lightspeed Venture Partners.

Ketryx, which was founded in 2021, is based in Somerville, Massachusetts and Vienna, Austria. It’s on a mission to make medical software quality assurance less error-prone, said CEO Erez Kaminski.

“Humans make mistakes. Computers do not. Traditional quality assurance uses humans to manually check thousands to tens of thousands of different line items before a product can go live. The average length of a 510k document according to the FDA is now over 2,000 pages, and we have customers who have submissions in the realm of 10,000 pages,” he explained.

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