Nexstim Looks To Break Into US TMS Market With Depression Indication

The Helsinki-based company had expected stroke rehabilitation to be the first FDA-cleared indication for its Navigated Brain Therapy system, but while more data is collected for that program, it is pursuing a 510(k) clearance for NBS to treat major depressive disorder and plans to build a US salesforce to market NBS for therapeutic indications.

Nestim NBT System
Nexstim's NBT System • Source: Nexstim PLC

Nexstim PLC has filed a 510(k) to US FDA for its NBT (Navigated Brain Therapy) transcranial magnetic stimulation (TMS) therapy system to be cleared for treating major depressive disorder.

Major depressive disorder is a chronic condition affecting 2%-5% of the population in developed countries. Current therapies, based on drugs...

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 Clinical Trials

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 

The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

More from R&D

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.