Neuronetics' FDA Nod Opens Doors to New CNS Market

The seeds planted in neurostimulation ventures over the past 10 years have produced more disappointments than results, but the fallow period is over. The Food & Drug Administration recently cleared Neuronetics to begin selling its NeuroStar TMS as a treatment for people who haven't responded to a drug regimen taken during their current episode of depression. This is good news for scores of venture-backed neurostimulation companies, although Neuronetics is somewhat unique. It is developing a non-invasive device that delivers magnetic, rather than electrical pulses.

More than a decade ago venture capitalists identified neurostimulation as a fertile new field for investment. The use of energy pulses—usually electricity—to manipulate the body’s nervous system had the potential to treat neurological, metabolic, and numerous other diseases. But those seeds planted in neurostimulation ventures over the past 10 years have produced more disappointments than results, with companies like LivaNova PLC and Northstar Neuroscience Inc. running into troubles over the past two years.

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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By 

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By 

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Abbott Embeds Libre Glucose Data In Epic EHR, Expanding Digital Health Footprint

 
• By 

Through this partnership, data stored in LibreView – Abbott’s cloud-based diabetes data management system – can automatically flow into Epic, allowing clinicians using Epic to view a patient’s CGM data before, during and after visits without toggling between systems or requesting manual uploads.