1. Medtech Insight
  2. >>Digital Technologies

FDA Issues Framework For Use Of Digital Health Technologies In Drug Development

 
• By Hannah Daniel

The FDA’s new framework for the use of digital health technologies will engage stakeholders to provide more guidelines for the industry.

• Source: Shutterstock

A new framework from the US Food and Drug Administration includes plans to harmonize guidelines between departments to encourage the use of digital health technologies (DHT) in drug development.

Under the framework, the agency will host workshops with key stakeholders and develop internal processes for DHT evaluation and drug...

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
Start Free Trial

Already a subscriber?

More from Digital Technologies

From Risk Aversion to Real-World Impact: How Medtech Firms Can Harness AI

 
• By Elizabeth Orr

Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

Medtech Sees Bigger Deals As Early Funding Tightens; LSI Is ‘Cautiously Optimistic’ For 2026

 
• By Marion Webb

Medtech funding in 2025 sees a trend of fewer, yet larger deals with total funding of $3.6bn in Q1, $2.6bn in Q2 and $2.9bn in Q3, said LSI’s Nick Talamantes. In 2026, he expects a continued investor focus on more mature firms in areas of oncology, cardiology and neurology.

Getting Comfortable With The Black Box: Explainable AI Techniques Build Trust

 
• By Bridget Silverman

A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.

More from Medtech Insight

Zimmer Biomet Readies Iodine-Coated Hip For 2025 Japan Launch, Plans To Expand Platform To New Joint

 
• By Shubham Singh

Zimmer Biomet is preparing to introduce iodine-coated hip implants to international markets, offering joint replacement patients a new alternative intended to ward off infection. The company intends to broaden the platform’s reach into “knees, shoulders and other categories in due time.”

From Risk Aversion to Real-World Impact: How Medtech Firms Can Harness AI

 
• By Elizabeth Orr

Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.