On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of COVID-19 treatments. With over 920,000 confirmed cases globally, the Coronavirus pandemic is forcing the FDA to create a rapid pathway for treatments.1...
With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry. Many industry groups and notified bodies have called upon the Commission to postpone the deadline until...
Earlier this month the ECRI Institute published its executive brief on this year’s Top 10 Patient Safety Concerns. The ECRI (formerly the Emergency Care Research Institute) is an independent nonprofit organization that focuses on conducting independent medical device evaluations to...
May 2020 deadline for the EU MDR is fast approaching and the industry is scrambling to find the right resources and understand the application of the regulation to their products. Unlike the FDA, the EU does not have clear directions on...
As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had to put precautions in place to protect the public. With over 93,000 confirmed cases world-wide, a global shortage...
The interoperability of medical devices is an important factor to consider especially with the increase in the digital health medical devices coming into the market. Medical devices should be able to safely and effectively exchange and use information or health...
In today’s modern era of the internet, it is a given that as medical device technology continues to develop, so will the number of devices that rely on network connectivity. The biggest market for these devices is healthcare clinics and...
The Emerging Medtech Summit 2020, organized by Life Science Intelligence, saw over 100 innovative medical technology startups from a multitude of medical modalities present their cutting-edge innovative technology and their plan for growth to gain strategic partnering and investment. The event...
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...