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Decentralized Trials Are Here To Stay; What Challenges Do They Face?

 
• By Barnaby Pickering

Decentralized trials took a leap in popularity over the past few years, in part thanks to the COVID-19 pandemic. Medtech Insight spoke to two executives at clinical research technology companies about running decentralized clinical trials to discuss the benefits and limitations of trials run remotely.

drug bottle on a trial form with a syringe
• Source: Shutterstock

Decentralized clinical trials, which use communication technology to avoid forcing patients to visit a central lab or clinic, are changing how drugs and devices are developed. 

They are less burdensome for patients, can reach underserved areas and, if designed well, provide more information to pharmaceutical and...

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CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

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Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Opinion: Catch A Fraudulent Scientist -- If You Can

 
• By Ivor Campbell

As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.