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Market Access

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Canada Launches Portal To Proactively Disclose Clinical Data On Approved Devices, Drugs

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.

Canada Clinical Trials Policy & Regulation
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UK Medtech Market Access: More About Mindset Than The Money

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.

Medical Device United Kingdom

“We Can’t Do It All Alone” Pfizer UK Tells Life Sciences Meeting

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.

Medical Device Market Access

European Commission Answers Vital Questions In Second Major Brexit Response

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.

Brexit Regulation

QUOTED. Feb. 21, 2019. Damien McDonald.

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.

Quoted Neurology

Vagus Nerve Stim Gets New Chance To Prove Its Worth For Depression

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.

Market Access Reimbursement

New Health Law Should Mean Faster Access To Diagnostics Innovation, Germany’s IVD Industry Says

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.

Germany Market Access
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