PwC’s Health Research Institute has released its 2020 Election Report, which includes an analysis of how President-elect Joe Biden's term will impact the healthcare industry. Ben Isgur, leader of PwC's Health Research Institute, guest star's on...
Court cases have established the means for determining the patent eligibility of diagnostic methods. Does your diagnostic pass the test?
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.
Investigators shared important late-breaking data on the Philips Stellarex paclitaxel-coated balloon Saturday morning at the virtual 2020 Vascular Interventional Advances conference.
A deep dive into how COVID-19 has forced many healthcare providers to adopt telehealth solutions, and some legal considerations for manufacturers.
Class I medical device companies have work to do, despite the UDI enforcement delay.
FDA's query for additional information includes requests for additional analysis of clinical data and proposes certain labeling modifications.