Somnera™ gets FDA Clearance with the Help of Galen Data
Somnera (formerly Fresca Medical) is a medical device company with a focus on sleep devices. The company developed an innovative low-flow positive airway pressure system for patients with obstructive sleep apnea. Working with a tight timeline, Somnera enlisted the help of Galen Data to achieve device-to-cloud connectivity in a fraction of the time (had they [&h
9 Medical Device Startups that Investors Love in 2021
Venture capital investments are the lifeblood of many successful technology startups, and medical device companies are no different. In fact, medical device companies often require more early-stage capital due to the capital-intensive nature of manufacturing a device and the clinical and regulatory requirements. With the much-needed capital and expertise these
California SB-327: The Security of Connected Devices
What California’s iOT Security Law Means for Medical Devices In September 2018, California’s governor signed Senate Bill 327, the Security of Connected Devices, into law, which went into effect on January 1, 2020. Its purpose was to extend already existing privacy laws to connected devices and the information they collect, store and transmit. Unlike the
Tips for a Successful Quality Audit
by Steve Ford, OMEDtech The medical device industry is a highly-regulated and constantly-evolving landscape, and, as a result of global and national regulations, there is an increased focus on auditing. It is critical to be prepared for third-party audits, as they are responsible for confirming your quality management system (QMS) compliance. Preventative audit
NIH and NSF Grants for Medical Device Startups
From concept to commercialization, the cost of launching a startup can seem overwhelmingly high. This reality is especially true for medical device startups, which require more capital than most prior to going to market. Thankfully, organizations like the National Institutes of Health (NIH) and the National Science Foundation (NSF) can help ease the initial cap
Implementing Medical Device Cloud Security
Buy vs. Build decisions cover myriad security issues and needs. Medical devices are increasingly becoming part of our daily lives. As they proliferate, the “bonus feature” of connectivity is quickly becoming a “must have” attribute for commercial success. Cloud connectivity helps meet the following market necessities: Collecting patient “vital sign”
How to Benefit from the New Medical Device Ecosystem
The New Medical Device Ecosystem: A transformation is underway in the realm of medical devices and medical sensor platforms — changing traditional definitions and creating new opportunities. In this report on Sensor Platforms, Cloud Connectivity, and the New Medical Device Ecosystem, we’ll define what constitutes an ecosystem and how medical device
Galen Data Partnership Protects Homebound Seniors During COVID-19
Homebound seniors with balance issues will benefit during COVID-19 from a new partnership between Galen Data and Zibrio. It’s the latest example of how medical device companies can take advantage of secure, scalable cloud connectivity. The patented Zibrio SmartScale measures physical balance and uses AI to predict an individual’s likelihood of falling &
Telemedicine: Reaching Beyond Traditional Methods
How is telemedicine transforming beyond traditional applications? Here’s how data connectivity is powering a new wave of telemedicine use cases:
Understanding How Artificial Intelligence Is Being Applied to Medical Devices
How are emerging technologies such as AI impacting medical devices? Here, Keith C. Drake, Ph.D., analyzes where we’re at now and developments happening into the future:
