FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.
As the incidence of GI conditions grows, device companies in this segment should explore expansion in the region.
The recently released draft guidance on cybersecurity stresses the importance of preparation versus reaction.
Announced at CES 2016, the cognitive app will leverage predictive analytics to help patients better manage their condition.
Changing the traditional healthcare model and moving from cure to prevention will take time.
Without financial incentives, pediatric device development won’t get the attention that it needs.
Prior to design verification of packaged products, consider the following process-related elements.
This three-part series explains how an all-encompassing testing approach will improve product reliability and secure your bottom line.
Not surprisingly, data science will reign over blockbuster drugs or devices.
Almost half as many devices were recalled this year compared to 2014.