Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation. The Volt system delivers high-energy electrical pulses to targeted areas of the heart to disrupt abnormal rhythms ...
In a significant move aimed at strengthening regulatory clarity for cancer related medical technologies, the Central Drugs ...
When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of ...
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