Press release
MedAware Systems Launches AI-Powered Post Market Surveillance for Catheter Introducers
MedAware Systems announces that its Science of Health Informatics (SOHInfo) Post Market Surveillance Service for Catheter Introducer devices is now available.SOHInfo monitors government regulatory adverse event databases, published literature, and social media to provide complete monitoring of the devices from all major manufacturers, including Steris Corporation, Sotera Health, Abbott, Cardinal Health, Merit Medical, Cordis Corporation, Terumo, Cook Medical, Teleflex, Medtronic, C.R. Bard, and others.
The surveillance system supports both FDA and MDR post market vigilance requirements with up-to-date and detailed event information on reported events, device problems, patient problems, and report sources. At-a-glance charts and tables quickly reveal overall activity for each product covered. Social Media posts are classified by positive and negative comments, malfunctions, general chatter, mentions of competitive products, and other key components.
“SOHInfo brings together data from scientific literature, regulatory reported data, and social media in one powerful analytics platform.” said William Kent, Chief Growth Officer. He continued: “Additionally, we offer data curation and meta-analysis of the published literature to inform CER, 510(k), ASUP, PMCF, and other regulatory filings with an unprecedented level of evidence.”
MedAware Systems, Inc.
3575 23rd St.
Boulder, CO 80304
ABOUT MEDAWARE SYSTEMS, INC.
MedAware Systems, Inc. is a next generation medical data company that empowers Pharma and Medical Device companies with all available evidence from published clinical trials research and event data from government regulatory reporting repositories and social media. The Company utilizes a combination of Human and Artificial Intelligence to make the vast body of data instantly available and indispensable for fully understanding the safety and efficacy of medical treatments and devices.
www.medawaresystems.com
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