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Only the combination group improved all of the following: Hemoglobin A1c (a measure of long-term blood sugar control) Insulin sensitivity (how well your body responds to insulin) Cardiorespiratory fitness (how efficiently your heart and lungs work) Bone mineral density (the strength of your bones) The medication alone did not improve fitness or bone health, and exercise alone did not improve blood sugar as much

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As noted earlier, a novel AI/ML device may still be substantially equivalent to a legacy 510(k) predicate based on older technology as long as the devices have the same intended use and technological characteristics

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Once this base is in place, more advanced therapies often work better and results last longer because your spine and muscles are already being supported