Digital Health Technologies In Clinical Studies Comes With Practical Challenges

Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.

Smartwatch
Patients generally prefer to wear their own smartwatch if one is needed for clinical trial participation. • Source: Shutterstock

[Editor's Note: This article originally appeared in Pink Sheet on 27 April.]

Digital health technologies hold tremendous promise in drug development, including bringing clinical trials to patients and providing a more consistent,...

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 Digital Technologies

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Corify Care, Mayo Clinic Join Forces To Advance AI-Driven Global Cardiac Mapping Platform

 
• By 

Corify Care’s CEO said the company aims to submit its 510(k) application to the US FDA by year-end, targeting market clearance in 2026. The company hopes its collaboration with the Mayo Clinic will help speed adoption of ACORYS, a noninvasive mapping technology for use in complex cardiac ablations.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

More from Medtech Insight

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.