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FDA Drops Draft Guidance For AI-Enabled Medical Device Developers

 

The US FDA has published a draft guidance document for developers of AI-enabled medical devices describing the postmarket management of their products. The guidance offers a comprehensive approach to the management of risk throughout the total product life cycle of a device.

CES 2025: Ever-Growing Digital Health Programming Brings DTx, Smart Homes, AI, AgeTech, Home Health, Wearables To Venetian

 
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Medtech Insight spoke with René Quashie, vice president of digital health at the Consumer Technology Association (CTA), about what to expect at this year’s CES show.

AI Adoption In Pathology Is Lagging: Funding And Clinical Standardization Needed

 

AI diagnostic biotech startup Owkin says AI adoption in digital pathology is slower than in radiology. In a new report, it identifies reimbursement structures and lack of funding and operational resources as barriers to faster adoption.

Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push, UK Pilots

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

Idea Lab Reimagines The Home As A Health Care Center

 

As part of its Home as a Health Care Hub initiative, the US FDA’s device center has unveiled an Idea Lab that includes a virtual reality experiencing offering an inside look at what is possible for patients receiving care at home utilizing the latest digital technologies.

Scotland’s Medtech Innovation Ecosystem On The Road To ‘Tipping Point’

 

Scotland has a strong foundation of medtech research, but to reach the ‘tipping point’ where it has gained critical startup mass, it must overcome funding challenges and foster corporate startup partnerships.

Medtech 2025 Expert AI Predictions: ‘Biggest Leap Leveraging AI In Oncology,’ Says Verily’s Andrew Trister; Multimodal Integration, Use Of AI Agents

 
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Medtech Insight asked three leading AI experts, Verily’s Andrew Trister, Ferrum Health’s Pelu Tran and Hologic’s Jennifer Schneiders, to offer their perspectives on the future of AI in health care.

UK Startup Lenus Health Partners With NHS To Deliver COPD Support

 

MHRA AI Airlock participant Lenus Health has secured three UK provider agreements for use of its COPD predictive AI risk stratification tool for use in the NHS.