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

Neuro Device Start-Ups Continue to Cause Headaches

Hopes have long been high for device innovations to treat a variety of neurological conditions ranging from stroke to migraines to depression. For all the promise these therapeutic areas hold, however, neurological device applications have proven to be among the most inscrutable for entrepreneurs and investors, replete with technological and clinical challenges. Several recent announcements have done nothing but confirm how challenging the neuro space is.

Ever since President Bush (the First) declared the 1990s to be the Decade of the Brain, hopes have been high for device innovations to treat a variety of neurological conditions ranging from stroke to migraines to depression. For all the promise these therapeutic areas hold, however, neurological device applications have proven to be among the most inscrutable for entrepreneurs and investors, replete with technological and clinical challenges.

Several recent announcements have done nothing but confirm how challenging the neuro space is. In fact, this year is starting...

More from Clinical Trials

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.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

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.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By Marion Webb

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

More from R&D

Abbott Launches Next-Gen Delivery System For Proclaim DRG Neurostim

 
• By Shubham Singh

Allen Burton, Abbott’s medical director of neuromodulation told Medtech Insight that the delivery system was developed to make the procedure easier for physicians, especially those who perform the implantations infrequently.

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.