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...
The European Medical Device Coordination Group published a joint implementation plan ahead of the May 2020 deadline for the full implementation of the EU MDR. The plan addresses the concern that the implementation of the MDR has proven to be...
As COVID-19 cases surge across the country, the health care industry is preparing itself to face ventilator shortages. There are fewer than 100,000 ventilators in the country. State and health officials are worried that if measures are not taken to...
With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international government agencies are either recommending or enforcing a “shelter in place” order to slow the spread of the disease.1 This is an unprecedented time...
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...
Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international travel restrictions, FDA released a series of advisories and statements to keep the public informed of the situation. The FDA is...
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...