Written by Admin | Jan 29, 2019 5:00:00 AM
{"id":"block_63b47bd4d6993","name":"acf\/block-rich-text-module","data":{"rich_text_module_0_content":"Boston, Massachusetts \u2013 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\u2019s regulatory strategy. These advances highlight PathAI\u2019s tremendous growth and commitment to the future of digital pathology.\r\n\r\n\u201cQuality 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,\u201d said PathAI co-founder and CEO Andy Beck. \u201cEsther 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.\u201d\r\n\r\nFor 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. \u201cIt\u2019s 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,\u201d said Lety Booth, PathAI\u2019s Director of Quality & Regulatory Compliance.\r\n\r\nIn 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.\r\n\r\n\u201cThroughout my career, I\u2019ve had opportunities to work on impactful projects in clinical research and advancing precision medicine,\u201d said Abels. \u201cI 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.\u201d","rich_text_module_0_button":"","rich_text_module":1,"jump_link_label":""},"align":"","mode":"edit"}