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Following in the footsteps of the European Medicines Agency, Canada has launched a publicly-accessible portal to proactively disclose clinical trial information on approved medical devices and drugs that was hitherto considered confidential.
Latest From Market Access
The journey from medtech concept to implementation is long and slow, and new ideas often don’t make it all the way to manufacturing and approval. But when they do, what is needed is a system that guarantees adoption and usage of those proven, innovative solutions that clear the many hurdles en route to clinical practice.
Incoming Pfizer UK country manager Ben Osborn outlined the delivery challenges ahead for health-care systems globally at the BioWales Showcase, in London in late February.
European Commission issues Q&A document to help industry understand specifics of “placing” products on the EU market in the context of Brexit, and what needs to be done regarding responsible persons, importers and certificate transfers.
Device-maker LivaNova will put its vagus nerve stimulation system to another sham-controlled test in patients with treatment-resistant depression by leveraging a newly finalized Medicare national coverage determination, which covers patients with bipolar disease. See what LivaNova CEO Damien McDonald said about it here.
The US Centers for Medicare and Medicaid Services loosened its long-running noncoverage policy for vagus nerve stimulation for treatment-resistant depression a little bit, with a tightly controlled coverage-with-evidence-development policy. Device-maker LivaNova hopes to launch a Medicare-covered study later this year.
Germany’s new draft health-care access law includes provisions to make the currently complicated, under-used and slow innovation "fast-tracking" tools more practical. Manufacturers of products that can address unmet needs should welcome the new TSVG law, currently in draft, says the national IVDs industry association. But it’s not all good news for industry.
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