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Exec Chat: Sequana Medical Pursues Dual Device-Drug Strategy For Fluid Overload

 
• By Barnaby Pickering

Speaking to Medtech Insight, Sequana Medical’s CEO discussed the company’s two technologies for combating fluid overload whilst explaining that, sometimes, chasing approval as a drug can be the best way to ensure easy market access.

Water and sodium: the two things Sequana Medical are developing technologies to remove • Source: Shutterstock

New drugs and devices appear to follow a similar path to market – an idea is formed, or a discovery is made, and then is developed into a product following regulatory approval.

But the differences between the drug and device regulatory and development pathways are significant, so companies typically focus on one...

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More from Clinical Trials

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

More from R&D

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

Home-Testing Added To UK National Cervical Cancer Screening Program

 
• By Natasha Barrow

NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.

Stealth Mode AI Imaging Startup Faction Imaging Raises $10M

 
• By Natasha Barrow

Faction Imaging has come out of stealth mode following six years of research and development studying medical imaging workflows in India, Japan and the US.