On Monday, the Centers for Medicare and Medicaid Services announced a proposed rule that would provide four year coverage for FDA-designated breakthrough devices starting from the date they receive U.S. marketing authorization. The proposed rule has been under deliberation since March 2019 and […]
ISPOR Short Course on Medical Devices is Tomorrow
The International Society for Pharmacoeconomics and Outcomes Research's (ISPOR) short course on market access and value assessment of medical devices is tomorrow (July 2). The online, 4-hour event is set to begin 10 a.m. EST. "Experience in launching pharmaceutical products can present both […]
Vizient’s Vega Talks Medical Device Industry, Value in Healthcare
In a recent interview with Evidera's Ann Menzie, Vizient's Patrick Vega discussed a number of topics, including key trends in the medical device industry and boosting value in healthcare. Vega says while there was often an informal approach to selling medical devices to hospitals, now "hospital […]
ISPOR-FDA Summit 2020 Nears
A joint summit hosted by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is set for March 31 in Silver Spring, Maryland. The ISPOR-FDA Summit 2020, which will be held at the FDA […]
Patient-Preference Data in Medical Devices to Take Center Stage at ISPOR-FDA Summit
An upcoming summit hosted by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in conjunction with the Food and Drug Administration (FDA) is set to focus on using patient-preference data in regulatory decision making for medical devices. The summit, "Using […]
White Paper Considers RWE in Medical Devices
A recent white paper by Evidera looks at what role real-world evidence (RWE) could play toward innovation in the medical device landscape. "Innovation of medical devices is often an iterative development process based on recognized need rather than transformational improvement to address a […]
