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CMS Policy Sets Boundaries On Transcatheter Valve Procedure

Final Coverage Plan Includes Compromise, But Maintains Evidence Development, Other Restrictions

New Medicare coverage policy for transcatheter aortic valve replacement is a significant step for the nascent procedure and a possible window into how the agency will address future high-profile, early-stage technologies.

A national Medicare coverage policy is now set for transcatheter aortic valve replacement, stabilizing the reimbursement environment for the new procedure, but also establishing a level of payer restrictions that is rare for a technology so early in its life cycle.

The TAVR procedure, an alternative to open heart valve surgery, is being touted as practice-changing by cardiologists and a blockbuster business opportunity for device companies. CMS' reimbursement approach to the...

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Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.