The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

The Food and Drug Administration clearance and CE mark position Abbott to sell its Amplatzer Piccolo Delivery System in the U ...

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 ...

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.

Artificial intelligence combines ultrasound and X-ray images to give physicians a real-time 3D view of the repair device during transcatheter heart procedures. Edwards’ Pascal and Abbott’s MitraClip ...

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.

The Houston-based startup is developing capabilities for endovascular aneurysm repair and stroke treatment that it hopes can bridge a skills gap and get patients treated faster.

Abbott has agreed to acquire cancer test-maker Exact Sciences for about $21 billion. Exact Sciences makes the Cologuard noninvasive screening test for colorectal cancer. The company also makes tests ...

While transcatheter aortic valve replacement (TAVR) remains Edwards’ largest business, the company is increasingly focused on driving adoption of treatments for mitral and tricuspid disease. Sales of ...