FDA Approves ReCor’s Renal Denervation System

The US FDA approved ReCor’s Paradise ultrasound renal denervation system, making it the first RDN system to reach the US market. Medtronic hopes its Symplicity Spyral radiofrequency RDN system will be the second RDN system on the US market, but it may face a more difficult path through the approval process.

blood pressure
• Source: Shutterstock

As expected, ReCor Medical’s Paradise ultrasound renal denervation system is now the first RDN system to earn US Food and Drug Administration approval.

The FDA approved Paradise as an adjunctive option for treating hypertension after lifestyle changes and medications have not adequately...

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

More from Approvals

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

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.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By 

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By 

NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

More from Policy & Regulation

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By 

Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By 

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.