Digital Health Roundup, January/February 2021: The Continued Rise Of AI, Telehealth

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from the year so far. 

Digital Health Roundup

The COVID-19 pandemic has exposed weaknesses in traditional health care systems, which has led to renewed interest in artificial intelligence (AI), specifically in applied diagnostics.

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‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 

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Smart, Silent And Streamlined: Abbott Rolls Out Universal FreeStyle Libre CGM App In US

 
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Abbott has also added new customization options to enhance user comfort and discretion. These include a “silent mode” feature for FreeStyle Libre 3 systems, allowing users to mute glucose alarms for up to six hours – a useful option during meetings, sleep, or other moments where audio alerts may be disruptive.

First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status

 

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New Semiconductor Tariffs Could Raise Device Costs

 
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Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

Smart, Silent And Streamlined: Abbott Rolls Out Universal FreeStyle Libre CGM App In US

 
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Abbott has also added new customization options to enhance user comfort and discretion. These include a “silent mode” feature for FreeStyle Libre 3 systems, allowing users to mute glucose alarms for up to six hours – a useful option during meetings, sleep, or other moments where audio alerts may be disruptive.