SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach ...

Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally ...

Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained ...

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this ...

The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.

The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J's expanding cardiac ablation ...

Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform ...

CathWorks FFRangio System employs drug-free, wire-free technology for comprehensive physiological assessment. Medtronic ...

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and ...