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AdvaMed Urges CMS To Leave MCIT In Place

 
• By Brian Bossetta

In a letter to CMS Administrator Chiquita Brooks-LaSure, the industry association argues that repealing MCIT would deny many Americans access to “transformational” medical technologies.

NEW TECH TIME
• Source: Alamy

There’s no argument that breakthrough medical devices have the potential to bring life-saving technology to patients. But the best way to get these devices covered under Medicare so beneficiaries can reap the promises they hold is not so clear.

In September, the US Centers for Medicare & Medicaid Services (CMS) proposed nixing the Medicare Coverage for Innovative Technologies (MCIT) rule, which industry has championed as a practical pathway to get breakthrough devices to Medicare patients quickly after they have been approved by the US Food and Drug Administration

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• By Natasha Barrow

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• By Neena Brizmohun

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New Semiconductor Tariffs Could Raise Device Costs

 
• By Elizabeth Orr

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AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 
• By Brian Bossetta

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

More from Policy & Regulation

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.