SOHInformatics

15/12/2021

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. Learn more at:https://medawaresystems.com/wp-content/uploads/2021/12/MedAware-Systems-Expands-Post-Market-Surveillance-for-Neuromodulation-Devices.pdf

31/08/2021

https://futurology.life/101-most-innovative-colorado-based-artificial-intelligence-companies/

Proud to be recognized as a leading company focusing on AI in healthcare. Our Advanced Intelligence application combines both AI and HI (Human Intelligence) to assemble massive data sets that deliver unprecedented levels of evidence on the safety and efficacy of medical treatments and devices.

This article showcases our top picks for the best Colorado based Artificial Intelligence companies. These startups and companies are taking a variety of approaches to innovating the Artificial Intelligence industry, but are all exceptional companies well worth a follow. We tried to pick companies

20/07/2021

MedAware Systems Launches Automated Post Market Surveillance for Closure Devices

We've added another product group to our AI-powered SOHInfo Post Market Surveillance service. We are completing the service to cover all Class III and Class IIA devices. Learn more at :https://medawaresystems.com/wp-content/uploads/2021/07/MedAware-Systems-Launches-Automated-Post-Market-Surveillance-for-Closure-Devices.pdf

06/07/2021

This Opinion (https://lnkd.in/eQJRWcx) from the EC reinforces the importance of comprehensive data for MDR submissions. The cost, in terms of time and effort, to resubmit can be significant, making "getting it right" the first time a priority. To see how MedAware Systems solves this problem, please visit www.medawaresystems.com.

Maximizing value from clinical trials research for Pharmaceutical and Medical Device Companies, Physicians, Payers, and Patients

01/07/2021

Post Market Surveillance for Catheter Introducers

We are pleased to announce the release of this new product group for our post market surveillance and product monitoring service.

For details, please see:

24/05/2021

In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR. These documents include: Clinical investigation – application/notification form under the MDR; Addendum to the clinical investigation application/notification form for various devices and sites; and Clinical investigation supporting documents.

Also included is an Appendix of documents to attach, Checklist of general safety and performance requirements, Standards, common specifications and scientific advice. Learn more at:https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf

10/05/2021

MedAware Systems Releases Cross-Platform Post Market Product Monitoring Service.

MedAware Systems announced the release today of its Science of Health Informatics (SOHInfo) cross-platform monitoring and surveillance management service. The AI-powered subscription application provides continuous monitoring and analysis on reported Adverse Events, Published Scientific Literature, and reported events on major Social Media platforms - keeping round-the-clock vigilance of pharmaceutical and medical device products.

Learn more at: https://lnkd.in/e2G-77u device