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CMS Jolts Shockwave; Ups Payment For Coronary Artery Disease Treatment

 
• By Brian Bossetta

The US Medicare agency increased payment for peripheral Intravascular Lithotripsy (IVL) procedures in a final rule. The increase is good news for Shockwave Medical, whose proprietary IVL treatment uses a novel approach to treating calcified arteries.

Broom Sweeping Out Arteries
• Source: Alamy

In its final payment schedule released on 2 November, the US Centers for Medicare & Medicaid Services (CMS) reassigned the payment for peripheral Intravascular Lithotripsy (IVL) procedures performed on above-the-knee (ATK) arteries in the hospital outpatient setting for calendar year 2022. The resulting payment increases for the procedures take effect on 1 January.

Included in the final rule are new Ambulatory Payment Classification (APC) assignments for three Healthcare Common Procedure Coding System (HCPCS)...

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Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 
• By Brian Bossetta

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By Elizabeth Orr

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
• By Amanda Maxwell

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

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Medtech Will Benefit From Boost To EU’s Quantum Technology Initiative

 
• By Amanda Maxwell

The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”

Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
• By Shubham Singh

Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By Marion Webb

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.