1. Medtech Insight
  2. >>Business
  3. >>R&D
  4. >>Clinical Trials

FDA Panel Votes Down Ablatherm HIFU Device For Prostate Cancer

FDA Gastroenterology and Urology Advisory panel members July 30 voted no confidence in the effectiveness and safety of EDAP TMS SA’s Ablatherm high intensity focused ultrasound thermal ablation device as a treatment for localized prostate cancer.

EDAP hopes to launch the product in the U.S. as an alternative to surgery, as it already does in Europe,...

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 Clinical Trials

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

More from R&D

Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups

 
• By Natasha Barrow

European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 
• By Natasha Barrow

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.