Concentric's Clearance Not Likely to Spur Stroke Investment

The FDA's unexpected decision to issue market clearance for the first medical device to treat ischemic stroke, Concentric Medical's Merci retrieval system, is not likely to dramatically increase venture investing in stroke start-ups because of a wide range of challenges facing product development and adoption in this space.

The FDA's unexpected decision in mid-August to issue market clearance for Concentric Medical Inc. 's Merci retriever system, the first medical device approved by the agency to treat acute ischemic stroke (AIS), is a dramatic success for Concentric. It also boosts a field that has seen its share of disappointment and has only one other FDA approved treatment option.

The agency's decision was a surprise to many because just six months ago, the FDA's Neurological Devices Panel, while agreeing...

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

UK’s Dementia Trials Accelerator Works To Fast-Track Trial Recruitment

 

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit

 
• By 

After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.

After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
• By 

Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

Apreo Health Raises $130M, First Patient Treated In US Clinical Trial

 

Apreo Health CEO Karun Naga talks to Medtech Insight about the company’s intentions for its Series B funding. The Breathe-3 clinical trial and early commercialization activities, involving physician education, are top priorities.

More from R&D

Apreo Health Raises $130M, First Patient Treated In US Clinical Trial

 

Apreo Health CEO Karun Naga talks to Medtech Insight about the company’s intentions for its Series B funding. The Breathe-3 clinical trial and early commercialization activities, involving physician education, are top priorities.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.