News

Galen Data and B-Secur announce partnership for next generation cardiac monitoring

Galen Data, the #1 software platform for medical device-to-cloud connectivity and data analysis, and B-Secur, an innovator in advanced biosensing technology, are pleased to announce a partnership aimed at providing enhanced cardiac health monitoring capabilities to cardiac device manufacturers. These capabilities include accurate, real-time monitoring, seamless cloud integration, robust data management, and Electronic Health Records integration.

For more details please read the press release here

September 26, 2023

FDA Guidance on Cybersecurity in Medical Devices

On September 26, 2023 FDA issues final guidance on Cybersecurity in Medical Devices: Quality System Consideration and Content of Premarket Submissions. This final guidance follows the draft guidance issues in 2022 and FDA’s Refusal To Accept policy issued in March 27 2023. The new Cybersecurity guidance replaces the 2014 guidance and is much more detailed [&h

November 12, 2020

Life-saving Device with Turnkey Cloud Connectivity | Galen Data

Galen Data Inc. and HeartHero, Inc. are proud to announce a partnership that will accelerate the commercialization of HeartHero’s life-saving emergency medical device. HeartHero, headquartered in Denver, CO, has developed a first-of-its-kind “smart” Automated External Defibrillator (AED) and is poised to deliver with Galen Data’s turnkey cloud platform

April 3, 2023

FDA Draft Guidance for AI/ML

On April 3, 2023 FDA release guidance around making changes to Artificial Intelligence (AI) and Machine Learning (ML) models categorized as Software as a Medical Device (SaMD) or as FDA calls it machine learning enabled software functions (ML-DSFS)In this draft guidance FDA lays out a new plan that can be submitted during your initial applications […]

November 18, 2020

Medical Device Cloud Connectivity Whitepaper | Galen Data

Galen Data Inc., announces the release of a 28-page whitepaper entitled “The Definitive Guide to Medical Device Connectivity” which offers in-depth guidance on device-to-cloud connectivity for medical device companies. The guide is co-authored by a team of leading experts in medical device design and development, who have a combined 50+ years of experience

Galen Data and B-Secur announce partnership for next generation cardiac monitoring

Related Posts

FDA Guidance on Cybersecurity in Medical Devices

Life-saving Device with Turnkey Cloud Connectivity | Galen Data

FDA Draft Guidance for AI/ML

Medical Device Cloud Connectivity Whitepaper | Galen Data

The Galen Cloud