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PathAI Earns Major Quality Certification, Expands Executive Team with Regulatory Expertise

Boston, Massachusetts – PathAI announced today that it has received certification of its quality management system for compliance with ISO 13485 and MDSAP for US regulations, an achievement that validates its approach to produce safe and effective medical device software to support pathologists and help detect and treat diseases like cancer. Additionally, PathAI announced the hiring of leading regulatory expert Esther Abels as the Vice President of Regulatory & Clinical Affairs and Strategic Business Development, leading the development of these medical devices and the company’s regulatory strategy. These advances highlight PathAI’s tremendous growth and commitment to the future of digital pathology.

“Quality is everything to us at PathAI, this external validation of the way we develop new technologies marks the beginning of a new chapter for us to bring accurate and predictive tools closer to patients,” said PathAI co-founder and CEO Andy Beck. “Esther Abels brings critical experience and a track record of rigorous execution to our team, which will help accelerate our ability to bring these tools to the market.”

For medical device companies, quality management systems (QMSs) are essential to sustainable implementation and maintenance, and regulators like the FDA require that a QMS conform to standards similar to ISO 13485. “It’s on us to demonstrate that we know what it takes to develop and ship a medical device, and the team here has shown exactly that,” said Lety Booth, PathAI’s Director of Quality & Regulatory Compliance.

In hiring Esther Abels, PathAI gains a wealth of savvy from her two decades in clinical research. Most recently, she worked as a Senior Director at Philips, where she led efforts to gain groundbreaking FDA approvals for whole-slide imaging systems. Abels has been serving on the board of directors of the Digital Pathology Association, where she has been Chair of the Regulatory and Standards Task Force for over six years.

“Throughout my career, I’ve had opportunities to work on impactful projects in clinical research and advancing precision medicine,” said Abels. “I am grateful to bring my experience to such cutting-edge technology that has the chance to change the way we think about diagnostics and treatment. I believe in the right treatment for the right patient at the right time.”

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