A bipartisan group of representatives introduced the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 to provide seniors access breakthrough devices.
On 22 March, a bipartisan group of representatives introduced an act to cover breakthrough devices. The legislation (H.R.4043) was introduced to the house by Representatives Brad Wenstrup (R-OH) and Suzan DelBene (D-WA), Gus Bilirakis (R-FL), Tony Cárdenas (D-CA), Blake Moore (R-UT), Terri Sewell (D-AL), Brett Guthrie (R-KY) and Anna Eshoo (D-CA).
The bill would require Medicare to cover devices designated by the US Food and Drug Administration as breakthrough products for...
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
Corify Care’s CEO said the company aims to submit its 510(k) application to the US FDA by year-end, targeting market clearance in 2026. The company hopes its collaboration with the Mayo Clinic will help speed adoption of ACORYS, a noninvasive mapping technology for use in complex cardiac ablations.
While European sustainability directives CSDDD and CSRD are still in the process of adoption, environmental group Swedwatch claims the EU's procurement framework is devoid of accountability.
