Boston Scientific ((BSX)) announced an update on their ongoing clinical study.
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Boston Scientific is currently conducting the SOCRATES study, officially titled ‘BoStOn SCientific Rhythm MAnagemenT REgiStry.’ This observational study aims to gather comprehensive data on the quality, performance, and safety of Boston Scientific’s cardiac rhythm management (CRM) devices over their entire lifecycle. The study is part of a post-market surveillance system required by regulations such as the EU Medical Device Regulation, ensuring the ongoing evaluation of medical devices.
The study involves the use of Boston Scientific’s CRM implants and electrophysiologic procedures. These interventions are designed to provide critical insights into the devices’ efficacy and safety when used alone or in combination with competitor products, following standard hospital care practices.
SOCRATES is an observational cohort study with a 10-year duration. It does not involve random allocation or masking, focusing instead on real-world data collection to assess device performance and safety. The primary purpose is to fulfill regulatory requirements and enhance product development.
The study began on March 18, 2021, with the latest update submitted on September 25, 2025. These dates are crucial as they mark the study’s progress and ongoing commitment to regulatory compliance and product improvement.
For investors, the SOCRATES study underscores Boston Scientific’s dedication to regulatory adherence and product safety, potentially boosting investor confidence and stock performance. As the study progresses, it may influence market dynamics, particularly in the competitive medical device industry.
The SOCRATES study is currently recruiting, with further details available on the ClinicalTrials portal.