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 ...

Abbott can now compete with Medtronic, Boston Scientific and J&J in the U.S. for the fast-growing pulsed field ablation ...

The Houston-based startup is developing capabilities for endovascular aneurysm repair and stroke treatment that it hopes can ...

As competition intensifies among surgical robot makers, CMR said its soft tissue platforms are the second most used systems ...

X9 is building an ultrasound-guided device used to simplify the process of inserting a needle for cannulation.

The company provided an update on its efforts to win market share, revealing that Maestro has been used to treat over 2,300 ...

SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.

Medicare reimbursement for aortic stenosis patients without symptoms could accelerate procedure growth for Edwards ...

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

Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.