Some worry that a provision in CMS’ proposed national coverage decision for transcatheter aortic valve replacement devices, which restricts coverage for off-label indications to trials designed to show superiority, signals the agency’s intent to play a more active role in dictating trial designs.
CMS’ proposal to limit coverage for unapproved transcatheter aortic valve replacement indications to clinical trials intended to prove superiority rather than non-inferiority to alternatives was widely panned by stakeholders in recent comments to the agency.
Some in the device industry worry the provision signals CMS’ intent to play a more active role in
Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.
Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.
Communication with patients has become a particularly crucial factor for investors, payers, and other healthcare decision-makers in a hostile market environment.
