Into 2019: Stakeholders Are Bidding To Re-Engage Medtech's Innovative Engine
"All-hands-on-deck" has been the policy pursued by the US industry association AdvaMed in recent times, as it has sought to play its part in promoting user-friendly, responsive and transparent regulation and market access for medical and digital health care technology. AdvaMed chair Nadim Yared believes that, with one or two noteworthy exceptions, there is more to come in 2019 from a largely improving medtech ecosystem globally.
You may also be interested in...
US medtech industry association AdvaMed issued a statement on Nov. 25 in reaction to recently published claims from a group of investigative reporters seeking to highlight what is wrong with the medical technology industry and what drives global innovators. The group, the International Consortium of Investigative Journalists (ICIJ), says it polled 250 journalists from around the world in a bid to assess how devices are tested, approved, marketed and monitored. Is their work balanced and fair, In Vivo asks?
Recently announced US National Evaluation System for health Technology "test cases" will be evaluated for up to a year by the NEST Coordinating Center after which collaborating device-makers may be in a better position to use real-world evidence to support new pre-market device submissions. The test cases will be measured, in part, based on their ability to identify brand-specific devices in the NEST Network Collaborators’ real-world datasets.
The Banyan Brain Trauma Indicator is the first blood test for detecting concussions in adults to reach the US market and the second device to emerge from US FDA's Breakthrough Devices Program. While test-maker Banyan Biomarkers originally flirted with the PMA pathway, FDA swayed it to the de novo process, which the firm ultimately leveraged to gain the market go-ahead.