The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Russia’s invasion of Ukraine has increased the potential for cyberattacks against U.S. healthcare systems.
Five steps to better protect providers, medtech companies, their networks, data and patients from a cyberattack.
Building fruitful development partnerships between companies, governments and researchers will enable the most promising and impactful deployments in healthcare.
Thus far, the company has received 51 reports of serious injury and three reports of patient death over five years.
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
A global pandemic is still upon us, but that certainly does not mean that healthcare technology innovation is standing still. To help the medical device industry look to the future and prepare, experts from regulation and academia alike are bringing attention to the acceleration and pitfalls of innovation.
Califf faced strong opposition but was confirmed in a very close vote.
Healthcare cannot remain reactive to dealing with cybersecurity risks. We must take a new, proactive approach to protecting our users, and our systems must prioritize reducing the extent of reliance on users against unknown threats.
The feeding set tubing can become wrapped around a child’s neck, leading to strangulation or death.
