By Michelle Tarver MD PhD & Angela Calman MPA – Thirty-five years ago, the U.S. Food and Drug Administration issued an alert that warned health care providers how certain electrically powered hospital beds could harm and even kill children. That was one of our earliest communications about medical device safety.Read More
By Brad Jolly – Heart disease continues to be a major health problem. The U.S. Centers for Disease Control and Prevention report it was the number one cause of death in 2019. In many cases, heart disease can be treated via lifestyle changes such as diet and exercise; in other cases, pharmaceutical approaches are useful.
By John Pizzonia – Post-pandemic, medical device companies need to reimagine approaches to accelerating Innovation. After spending more than 20 years of my career in R&D with leading medical device and life sciences companies, it’s no secret to me that speed matters when it comes to product development and go-to-market.
By Jessica Serrao – Medical device alarms are meant to detect and alert caregivers to life-threatening situations, life-threatening device malfunction, and imminent danger to the patient. Within the critical care setting, however, studies show that more than 87% of device alarms require no medical action or attention.
By Devin Partida – When the COVID-19 pandemic first began causing problems around the world, health care professionals often had to adjust their practices as new research became available. However, one thing that was clear from the start was the need to maintain effective sterilization techniques.
By Jeff Shuren MD JD & Ed Margerrison PhD – Progress in science and technology offers extraordinary opportunities to develop innovative medical products that can save lives and lead to better treatments, better diagnostics and better care for patients.
By Jeff Shuren MD JD & Daniel Caños PhD MPH – Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation.
By Stephen M. Hahn MD – One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections.
By Christophe Dore – Healthcare is digitalizing more information and connecting more information systems than ever before to enhance patient care and operational efficiency, with the expectation the synergies between these systems will create additional value.