FDA Clearances for World’s Smallest Insulin Pump + New Cardiac Biomarker Test

In this episode, Ayesha talked about the FDA clearance of the world’s smallest insulin pump from Tandem Diabetes Care. The insulin pump, called the Tandem Mobi, features an automated insulin delivery system with options for manual delivery as well. The device is small enough to fit into the coin pocket of a pair of jeans and offers several wearable options. It can be operated through an app and also features technology compatible with continuous glucose monitoring systems. 

Ayesha and the team also discussed the FDA clearance of the first FDA cleared NMR-based test from Numares Health. The company’s AXINON test system measures levels of low density lipoprotein particle (LDL-p), which the company touts as being a more robust biomarker than LDL-cholesterol (LDL-c) for evaluating cardiovascular disease risk. Hear more about the test, including some of its other disease applications, in this episode.  

Read the full articles here:

Tandem Mobi Becomes World’s Smallest Insulin Pump with FDA Clearance

New Cardiac Biomarker Test Gets FDA Clearance

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