1. Medtech Insight
  2. >>Business

Cardio Catch-Up: FDA Approves Edwards Evoque Transcatheter Tricuspid Valve Sooner Than Expected

 
• By Reed Miller

Edwards' Evoque is the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation. The FDA-approved labeling says it can improve patients' "health status" but the company may be able to soon upgrade that indication to include a mortality benefit claim, which could give Evoque an important advantage over tricuspid valve repair devices.

Edwards' Evoque transcatheter tricuspid valve
• Source: Edwards Lifesciences

The US Food and Drug Administration approved Edwards Lifesciences’ Evoque tricuspid valve replacement system to improve the “health status” of people with symptomatic severe tricuspid regurgitation.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status

 
• By Natasha Barrow

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
• By Marion Webb

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 
• By Natasha Barrow

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.

More from Medtech Insight

Cleveland Clinic Collaborates Successfully Across 7,000 Miles To Perform First Robotic-Assisted Focal Therapy For Prostate Cancer

 
• By Marion Webb

Urologists at the Cleveland Clinic in Ohio and Abu Dhabi collaborated successfully to perform the first transcontinental robotic-assisted focal therapy for prostate cancer using EDAP’s Focal One HIFU robotic system. The procedure served as proof of concept for future teleprocedures. EDAP’s CEO Ryan Rhodes told Medtech Insight other hospitals are also showing interest in this type of collaboration.

Keep An Eye On Landmark Global Pandemic Treaty, Experts Advise

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

New Semiconductor Tariffs Could Raise Device Costs

 
• By Elizabeth Orr

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.