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Digital Health Technologies In Clinical Studies Comes With Practical Challenges

 
• By Sue Sutter

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,...

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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

 
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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.

ForSight Sets Its Sights On Automating Delicate Eye Procedures

 
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Rising Oncology Start-ups Recognized For Breakthrough Cancer Research

 
• By Natasha Barrow

The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.

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