The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward. Read More
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. Read More
SAN FRANCISCO – Abbott Laboratories expects that its self-expanding transcatheter aortic valve replacement (TAVR) system Portico will be able to become a top competitive product. A pivotal trial of Portico has found that the implant is noninferior to current FDA-approved TAVR systems that are marketed in the U.S. The results from the 750-patient, randomized trial were presented here last week at the Transcatheter Cardiovascular Therapeutics (TCT) conference. Read More
