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

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.

Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges ahead. Patient advocates, who have called for stronger device standards and ...

Artificial intelligence was a topic of focus for the medical device industry in 2024. The Food and Drug Administration recently clarified what information it wants to see in future submissions as the ...

Under the second Trump administration, the EPA said in March it planned to reconsider emissions standards for facilities that sterilize medical devices. At the time, the agency said it would consider ...

The Food and Drug Administration convened an advisory panel on Friday to discuss concerns that pulse oximeters may be less accurate in people with dark skin pigmentation. The agency asked panelists ...