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A graphical look at some of the key changes to expect in industry fees and FDA performance commitments based on a draft deal to reauthorize the medical device user fee program (MDUFA VI).
In the ALLEVIATE-HF clinical trial, continuous monitoring provided by Medtronic’s insertable cardiac monitor revealed a substantial burden of previously unsuspected arrhythmias in patients with both HFrEF and HFpEF—many of whom would not ordinarily qualify for an implantable cardiac device.
New device-based interventions for AAA may offer an alternative to prolonged surveillance in treating abdominal aortic aneurysms. Excerpted from our recent MTS feature, "Living Under Surveillance: Can New AAA Treatments Change the Story?"