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The device makes it “possible to uncover elevated risk for these complications earlier and more accurately than traditional clinical approaches,” the company said.
Diabetes nonprofit organization Tidepool has received FDA clearance for its crowd-sourced Tidepool Loop, the first automated insulin dosing app that works from an Apple Watch.
Cancer care and software technology maker Varian announced that the FDA has granted an investigational device exemption (IDE) for a pivotal multi-center, international trial of its cardiac radioablation (CRA) system for patients with high-risk refractory ventricular tachycardia (VT). Read More
The FDA has sent Surmodics a Complete Response Letter for its SurVeil drug-coated balloon, asking the company to amend its premarket approval application (PMA) to add information on biocompatibility and labeling.