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 ...

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

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

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

Shorter, nanosecond pulses for treating atrial fibrillation differentiate the company’s approach from existing pulsed field ...

Medtronic and CMR Surgical got the FDA’s green light this month, while SS Innovations applied for clearance. Catch up on the ...

The legislation makes no mention of the financial assistance, setting the subsidies up to lapse in just a few weeks.