Press release
MedAware Systems Expands Neuromodulation Device Regulatory Data Portal
MedAware Systems announced today a major expansion of Neuromodulation device data in its SOHInfo (www.sohinfo.com) customer portal. The portal is populated with reported data from registries, published literature, and social media for all registered devices for Spinal Cord Stimulation, Peripheral Nerve Stimulation, Ganglia Dorsal Root Stimulation, RF Ablation, Parkinson - Deep Brain Stimulation, Sacral Stimulation – Incontinence, and others. Global regulatory reported data is provided on all manufacturers’ products for each product class.The SOHInfo portal gives customers the ability to easily group, chart and analyze data to support their entire organization, from regulatory to medical affairs to marketing and more.
Features include: real time trend analysis and comparison of all products to quickly identify issues; complete FDA data for MAUDE, recall alerts and field safety notices; Adverse Events from the published scientific literature, broken down by population group; product-related social media posts; and total Life Cycle Data.
“Coverage of data from global regulatory data repositories, published scientific literature and social media, in one affordable application, offers tremendous time and cost saving.” said Michael Willis, CEO. He continued: “Customers are provided unprecedented levels of evidence and an evergreen data source that significantly reduces time, effort, and cost for first-time and on-going filings such as CER, 510(k), ASUP, PMCF. The data and analyses support many other business requirements as well.”
MedAware Systems, Inc.
2525 Arapahoe Avenue
Suite # E4-196
Boulder, CO 80302
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, 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.
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