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Alere Medical and its now-defunct subsidiary Arriva Medical will pay the US government $160m to settle allegations that they violated the False Claims Act. It’s the second settlement that Alere has entered into with the Department of Justice in recent weeks.
In an interview with Medtech Insight, Andy Molnar, new CEO of the Digital Therapeutics Alliance, outlines some of the big issues facing the digital therapeutics industry, which has seen tremendous growth during the pandemic.
On this week’s podcast we highlight US Medicare reimbursement topics that industry should keep an eye on, and discuss important regulatory changes underway in the UK.
Four US senators are leading a bipartisan effort to bring potentially life-saving medical treatments to Medicare beneficiaries by requiring reimbursement for breakthrough technologies cleared by the FDA.
The US FDA needs enhanced authorities as well as increased funding to track and prevent device shortages, acting commissioner Janet Woodcock argues.
The US Medicare agency's new rule for facility fees brings more bad news for Glaukos; Wells Fargo downgrades company’s stock in response.
Proposals from the US Centers for Medicare & Medicaid Services (CMS) would help make telehealth a permanent fixture across the healthcare landscape, particularly for treating mental health.
In this week’s podcast, EU regulatory editor Amanda Maxwell walks us through the latest news and documents coming out of the European Union’s efforts to revamp its medical device and diagnostics rules and makes some predictions about what we can expect to see going forward.
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