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

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

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

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

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

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

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

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

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

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

Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical ...

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...