B. Braun Interventional Systems Inc. (BIS) announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR).

Dassault Systèmes announced the five-year extension of its collaboration with the U.S. Food and Drug Administration (FDA). The 3DEXPERIENCE platform will be used to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices. Researchers hope the process will increase industry innovation and pave the way for an efficient path for patients to access safe, effective new treatments for the world’s leading cause of death – heart disease.

Clinical trials are a critical tool for getting new treatments to people who need them, but research shows that difficulty finding the right volunteer subjects can undermine the effectiveness of these studies. Researchers at Cincinnati Children’s Hospital Medical Center designed and tested a new computerized solution that used artificial intelligence (AI) to effectively identify eligible subjects from electronic health records (EHRs), allowing busy clinical staff to focus their limited time on evaluating the highest quality candidates.

The chances of patients experiencing complications after having a cardiac device implanted vary according to where they have the procedure.

High blood pressure among children is on the rise and a lack of research about how to treat it has left pediatricians trying to make their best guess. That’s until researchers at The University of Texas Health Science Center at Houston (UTHealth) released results of a pioneering study that used a series of personalized trials to identify a preferred therapy for kids – the first step in tackling the problem.