The first day of a two-day U.S. FDA advisory hearing on the use of paclitaxel devices for the lower limbs was a study in different narratives. The FDA said five-year mortality was higher for drug-coated balloons (DCBs) and stents, despite the agency's seeming inability to establish any causative factor. Device makers received some support from the clinical community in the criticism of the FDA analysis and the journal article that started the conversation on several points, including that the clinical studies in question were not designed to evaluate mortality at five years. Read More
The digital therapeutics market is witnessing considerable growth globally thanks to the confluence of the development of new technologies, the increasing prevalence of chronic diseases and lifestyle-associated diseases and an aging population. Exactly how the technology will impact the health care milieu was the subject of a panel held at the Biotechnology Innovation Organization's 2019 international convention earlier this month, organized by Accel-Rx, Canada's health sciences accelerator that supports promising early stage companies developing therapeutics, diagnostics and medical devices. Read More
