The Aurora EV ICD system provides anti-tachycardia pacing, cardioversion and defibrillation therapies through a lead placed under the breastbone, outside of the heart and veins.
Medtronic’s Aurora EV ICD system will be the first extravascular implantable cardioverter defibrillator available in the US.
On 23 October, the US Food and Drug Administration approved Aurora to provide defibrillation shocks, anti-tachycardia pacing (ATP), and...
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
