The US Medicare agency opened a national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators and received input from 35 individuals, organizations, and companies during the initial public comment period. The agency did not specify any particular issues or deficiencies that it wants to address by updating its coverage policy, but CMS has not reconsidered the national coverage policy on ICDs since a major coverage expansion was implemented in 2005.
The US Centers for Medicare and Medicaid Services is considering updating its national coverage policy for implantable cardioverter defibrillators for the first time in twelve years.
The agency formally opened the review of its national coverage policy for ICDs – Section 20.4 of the...
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.
Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.
