News We’re Watching: Medicare Payments For Renal Denervation; Acquisitions for Tempus And Boston Sci; LumiThera And Caris Land FDA Authorizations

This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.

"News We're Watching" Feature Image
• Source: Medtech Insight

Renal denervation systems from both Medtronic and Recor have been approved for Transitional Pass-Through (TPT) payment by the Centers for Medicare and Medicaid Services, the companies announced last week.

More from Medtech Insight

HHS Restructuring And Job Cuts Could Weaken FDA, Experts Say

 

About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department. Experts questioned whether the cuts could be implemented without harming FDA’s core mission.

LSI 2025: Vektor Medical CEO Says ‘Arrhythmia Is The Biggest Health Care Crisis Nobody Talks About,’ vMap Treats It With 91.1% Accuracy

 
• By 

Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.

Get A Grip On Healthcare And Tariffs German Medtechs Tell Incoming Coalition

 
• By 

The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.

THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

More from Approvals

Hologic Upgrades Aptima SARS-Cov-2 Assay Authorization To Full FDA Approval

 

Hologic attains full US Food and Drug Administration 510(k) clearance for its Aptima SARS-CoV-2 assay, which reached market under an Emergency Use Authorization (EUA). Overall, Hologic’s “best-performing” molecular diagnostic business continues to grow despite the decline in revenue for COVID-19 assays and related items.

Boston Scientific Sets ‘New Clinical Innovation Standard’ For Pulsed Field Ablation

 

Boston Scientific has integrated cardiac mapping and pulsed field ablation into a single catheter with the newly EU-approved Farawave Nav Ablation Catheter. Faraview Software also receives CE marking, allowing for visualization of catheter placement when delivering therapy.

Inflammatix Receives FDA Clearance For Blood Test To Help ER Clinicians Diagnose Infections, Sepsis

 
• By 

Inflammatix received US FDA clearance to market its TriVerity Test System to help emergency departments quickly triage patients suspected of having acute infection or sepsis. Medtech Insight spoke with Inflammatix CEO Tim Sweeney about the company’s business strategy and marketing plans.