SOHInformatics

18/02/2022

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

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:https://medawaresystems.com/wp-content/uploads/2021/06/MedAware-Systems-Launches-Catheter-Introducer-Post-Market-Surveillance.pdf

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

23/04/2021

New MDCG 2021-6 on Clinical Investigations

The Medical Device Coordinating Group (MDCG) published new guidance on clinical investigation and evaluation. The document offers useful summaries on how clinical investigations are defined and on performance and benefits reporting.

https://www.linkedin.com/pulse/new-mdcg-2021-6-clinical-investigations-wiebe-postma/?trackingId=UxfjQUqWWVLmnmDK9nx1Tg%3D%3D

Published: April 23, 2021. Yesterday (22 April) the Medical Device Coordinating Group (MDCG) published a new guidance in the category of clinical investigation and evaluation: MDCG 2021-6 “Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation”. This important ...

23/03/2021

MedAware Systems announces that its Science of Health Informatics (SOHInfo) Post Market Surveillance Service for Cervical Disc Replacement devices is now available.

SOHInfo monitors government regulatory adverse event databases as well as relevant published literature to provide complete monitoring of devices from all major device manufacturers. The Service also offers comprehensive visibility and active alerts across all three major social media platforms: LinkedIn, Facebook, and Twitter. Learn more at:

https://lnkd.in/eGQQxUR

12/03/2021

An excellent article discussing the various requirements for class II and III device certification. MedAware Systems' Advanced Intelligence Surveillance and Data Services are purpose-built to rapidly and comprehensively address these requirements.

Advanced Intelligence is the unique combination of Artificial and Human Intelligence that saves considerable time, effort, and cost in the development of CER's and ongoing post market surveillance. .

https://www.linkedin.com/posts/michael-willis-a5625585_ai-surveillance-data-activity-6776181803892977664-ENY1

The SOHInfo platform provides you the ability to apply knowledge-based solutions to any medical subject based on all available scientific data. You can identify optimal treatments and predict outcomes, down to specific patient profiles, using SOHInfo to investigate entire domains of medical science.

09/03/2021

MedAware Systems’ Science of Health Informatics (SOHInfo) announces a major upgrade of its medical device surveillance service to include reporting on social media posts.

This new functionality supports both FDA and MDR post market vigilance requirements. Learn more at:https://medawaresystems.com/wp-content/uploads/2021/03/MedAware-Systems-Upgrades-Medical-Device-Surveillance-with-Social-Media-Reporting-1.pdf