Quite often, medical device executives are apathetic towards biocompatibility testing, rightfully questioning, “So what?” and trying to delay it as much as possible. However, postponing biocompatibility testing too long may lead to financial loss and even further delays in the commercialization of the medical device. Therefore, it is most advantageous for medical device companies to […]
-Shu Xiang (Regulatory Affairs Specialist, Mittal Consulting) House Committee Advances Bill for CMS Coverage of Breakthrough Medical Devices A bill that would mandate the Centers for Medicare and Medicaid Services (CMS) to provide expedited temporary Medicare coverage of breakthrough medical devices cleared the House review committee, pushing it further along the legislative path. The Breakthrough […]
Elle Winn What is EtO Sterilization? Ethylene Oxide (EtO) gas sterilization is one of the most common sterilization methods used for medical devices. The practice is critical to sterilizing temperature- or moisture-sensitive devices1 and is very efficient for sterilizing devices with complex geometries with limited access2. For some devices, EtO gas sterilization is the only […]
