Could MedTech find itself as the collateral damage if an RFK Jr. run HHS “goes wild” with FDA regulation of pharma and ...

Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a ...

EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to ...

In the face of sweeping Medicare changes for 2025, millions of seniors face the challenge of navigating a complex landscape of new options, increased costs, and altered benefits. Innovative ...

As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations ...

The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ ...

With numerous planned submissions underway for 2024, the new platform is setting a new standard for managing simultaneous ...

Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high ...

Health equity can provide equal opportunity for patients to achieve the best care possible. Medtech leaders from Boston Scientific, Sequel Med Tech, and ZEISS Medical Technology share how healthcare ...

Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical ...