As digitalization increases all around us, computer programs have also been making their way into our healthcare system. Software product developers must comply with various regulatory requirements depending on the intended use of the products...
The Dublin-based company inherited the DiamondTemp Ablation (DTA) system when it acquired Epix Therapeutics for $316 million in 2019.
FDA has added five tools to its catalog of regulatory science tools to help assess medical devices.
The Marlborough, MA-based company received CE mark for the Vercise Genus Deep Brain Stimulation (DBS) system in September of 2020.
In November of 2020, Qiagen decided to proactively withdraw the first emergency use authorization submission to address a chemistry-related issue.
Response to the pandemic fast-tracked the pace of medtech innovation. In the future, can a human-centered iterative approach to design controls help maintain that momentum?
Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities.
News Editor Amanda Pedersen shares her thoughts on the Affordable Care Act as the U.S. Supreme Court hears oral arguments to overturn the legislation.
A deep dive into how COVID-19 has forced many healthcare providers to adopt telehealth solutions, and some legal considerations for manufacturers.