FDA Designates NyokAssist As A Breakthrough Device

With the majority of devices manufactured outside the United States, any increase in tariffs is likely to drive up health care costs, according to a GlobalData analysis.

Tarver takes over the lead role at CDRH after serving as interim director since July.

The TensWave is designed to provide user-friendly pain relief, complementing Zynex’s NexWave electrotherapy device.

Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.

Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.

Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.