MDUFMA Renewal Plan Spreads Fee Burden More Evenly; Senate Panel OKs

Just two days after FDA released its behind-schedule proposal to reauthorize the medical device user fee program, a Senate committee approved the agency's recommendations to collect almost $300 million from manufacturers through 2012

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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

 

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
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Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.