NATIONAL HARBOR, Md. – Berlin-based Biotronik SE & Co. reported new data from the BIOFLOW-V trial showing that its Orsiro ultrathin strut drug-eluting stent (DES) continued to outperform Abbott Laboratories’ Xience DES through three years’ follow-up.
NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
Medical device companies are seeking to reduce product defects and increase patient safety with an industry-managed program that focuses on final product quality via oversight of the most critical manufacturing processes. Modeled on a 30-year-old aerospace industry program called Nadcap, Medaccred brings device manufacturers and suppliers together to define accreditation for special processes.
SEATTLE – As it enters its third year, the Human Cell Atlas project has mapped 100 million of 100 billion cells, and by comparing gene expression profiles of normal and aberrant cells and building networks of cellular interactions, is leading to breakthroughs in understanding of disease at a molecular level.
SEATTLE – Tracing the family tree of COVID-19 through its evolving DNA sequence makes it possible to disprove many false claims circulating on social media about the novel coronavirus, and, in particular, that it was generated in a covert biological weapons program.
ANAHEIM, Calif. – Most medical device manufacturers follow a traditional, linear, task-driven approach for product development. Switching to a knowledge-driven approach, called agile-lean, may yield better results. That was the takeaway from a talk at MD&M West.
ANAHEIM, Calif. – The digital health wave is impacting seemingly every aspect of health care, from digital therapeutics where software is the therapy to powerful analytics that bring actionable insights to aid in a clinical situation.
SANTA CLARA, Calif. – Diabetes seems likely to be the first area to really show concrete products and results for the ambitious Verily Life Sciences, which is the med-tech business of Mountain View, Calif.-based Google parent Alphabet Inc. However, its two major diabetes partners both have been rethinking the relationship.
SANTA CLARA, Calif. – While many of the presentations at the Precision Medicine World Conference revolved around clinical studies and their promise for future breakthroughs in health care, a continuous stream of companies made their pitches for translating these studies into actual products that can benefit patients now.