Ketryx Secures $39M to Transform Compliance in AI-Powered MedTech

Ketryx, a fast-rising compliance technology startup with bases in Cambridge and Vienna, has raised $39 million in a Series B funding round led by Transformation Capital. The company has now raised over $55 million in total funding, demonstrating its growing confidence in its goal of modernizing the way AI-driven health firms and manufacturers of medical devices handle regulatory requirements. Additionally, Lightspeed Venture Partners, MIT's E14 Fund, Ibiquity Ventures, and 53 Stations continued to support the round.

The platform developed by the startup is intended to address one of the most challenging obstacles in healthcare: striking a balance between innovation and stringent safety and regulatory requirements. Ketryx automates validation traceability and compliance reporting, including FDA and EU MDR documentation, through the use of artificial intelligence. Through the direct integration of compliance into development processes, the system assists medtech companies in expediting product launches while adhering to regulatory guidelines.

Early results show that the platform’s impact is substantial. Customers have reported up to a 90 percent reduction in the time needed for regulatory paperwork and product development cycles that are more than ten times faster than traditional methods. These gains make it possible for innovators to bring safer medical technologies to market more quickly, bridging the gap between regulatory rigor and the fast pace of AI-driven healthcare.

Leaders in the industry have already adopted Ketryx's technology. Aignostics Heartflow DeepHealth and other AI health innovators use its platform, as do three of the top five medical device companies in the world. Collaborations like these demonstrate the practical faith in Ketryx's capacity to expedite compliance without sacrificing patient safety.

The new funding will support hiring more staff, expanding internationally, and developing new products. Transformation Capitals Vinay Shah joined Ketryx's board as part of the round, and former Medtronic CEO Bill Hawkins also invested. Their participation demonstrates a strong conviction that Ketryx has the potential to become the global leading compliance backbone for MEDtech innovation. The company is setting itself up to make sure that regulatory complexity never impedes life-saving advancements, given the rapidly increasing demand for AI-powered medical solutions.