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

SoniVie, ReCor Move Forward With Ultrasound Renal Denervation Technologies

 
• By Reed Miller

The FDA granted its breakthrough designation to SoniVie’s TIVUS and ReCor's Paradise ultrasound renal denervation systems for treating hypertension.

Man self-monitoring of blood pressure with a tensiometer
• Source: shutterstock.com (Shutterstock)

SoniVie is planning to begin US clinical trials of its Therapeutic Intra-Vascular Ultrasound (TIVUS) renal denervation system to treat drug-resistant hypertension in late 2021 while continuing to develop the system to also treat pulmonary hypertension.

TIVUS is a catheter-based high-frequency, non-focused ultrasound system for ablating arterial nerves. It was originally developed by Israel-based Cardiosonic for...

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

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

More from R&D

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

Home-Testing Added To UK National Cervical Cancer Screening Program

 
• By Natasha Barrow

NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.

Stealth Mode AI Imaging Startup Faction Imaging Raises $10M

 
• By Natasha Barrow

Faction Imaging has come out of stealth mode following six years of research and development studying medical imaging workflows in India, Japan and the US.