The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making.

BOGOTA, Colombia – During the past few years, the Dominican Republic has become one of the leading medical device suppliers to the U.S. It has positioned itself as the Latin American country with the highest export value of medical and surgical instruments worldwide. This year, it aims to expand its med-tech exports at a 7% rate.

PARIS – Microlight3D SAS, based in La Troche, France, is about to receive a $900,000 grant from the EU to develop new 3D printer technology dedicated to treating acute wounds and chronic ulcers that do not heal. "It's about developing a novel process based on ion-releasing biomaterials promoting angiogenesis for skin regeneration," Denis Barbier, optoelectronics laser specialist and CEO of Microlight3D, told BioWorld.

SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.