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Set Alert for Reimbursement

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

What’s New In Digital Therapeutics? Investment Strategies, Reimbursement And More From DTA Annual Summit Day 1

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

DTA Digital Health

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

Europe EU

FDA Implements Authority To Destroy Certain Medical Devices, Amends Final Rule To Provide Device Owners Prior Notification

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

FDA Enforcement

Feedback Sought On Managing Conflicts of Interest Under EU HTA Regulation

Representatives and individual experts taking part in joint assessments of new health technologies need to be free from conflicts of interest in relation to the industrial sector in which the health technology developer operates.

Europe Health Technology Assessment

Telehealth Experts Discuss Access In Health Care Deserts, Overcoming Provider Resistance, Liability Concerns

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

Digital Health Telehealth

FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

FDA OTC Devices

New China Tariffs Include Higher Rates For Syringes, PPE

Medical products imported from China are among a broad range of items that will be subject to higher tariffs under new federal guidelines. The plan will raise tariffs on some forms of personal protective equipment (PPE) to 25%; additionally, tariffs on syringes and needles will be set at 50%.

Trade Policy Regulation

An Ecosystem For Medtech Funding And Innovation Support – BioWales 2024

Creo Medical and Clinithink are among healthtech innovators that have benefited from funding and advisory support offered by the Development Bank of Wales. All three gave a take on the current funding environment at BioWales in London 2024.

Market Access United Kingdom

Expert Proposes AI Device Reimbursement Model ‘Like Netflix’

Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement. 

Artificial Intelligence Reimbursement

Front Line Medical Technologies Announce CE Mark For COBRA-OS

Front Line Medical Technologies Inc.'s new CE marking expands access of its occlusion device COBRA-OS to medical providers in Europe. Adam Power, chief medical officer at Front Line Medical, talked to Medtech Insight about their marketing plans and benefits of the technology. 

Approvals Europe

UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026

Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.

United Kingdom Policy

It’s Been Over 1100 Days Since MCIT, Still No TCET In Sight

AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.

Medicare Reimbursement

Ekso's Exoskeleton Receives Medicare Coverage, Paves Way To Faster Rehabilitation

Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.

Reimbursement Medicaid

News We’re Watching: Lung Preservation System Goes National, De Novo For MMI, Brazil’s ANVISA To Recognize Overseas Approvals

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Regulation Commercial

FDA Asked To Withdraw Approval Of Test Evaluating Opioid Addiction Risk

Dozens of researchers signed a letter condemning the AvertD test from SOLVD, which looks for genes that may contribute to a propensity toward opioid addiction. But the FDA and the manufacturer both say the test is effective.

Behavioral Health Approvals
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