The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.
The company received three complaints about patients who had perforation injuries linked to the devices.
The request for information comes as the Trump administration has largely taken a deregulatory stance on AI, in a bid to ...
The Food and Drug Administration clearance and CE mark position Abbott to sell its Amplatzer Piccolo Delivery System in the U ...
Abbott can now compete with Medtronic, Boston Scientific and J&J in the U.S. for the fast-growing pulsed field ablation ...
MiniMed is pitching the breadth of its portfolio as an advantage over more focused rivals such as Dexcom and Insulet.
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