FDA Designates NyokAssist As A Breakthrough Device

ARC-EX is the first FDA-approved technology shown to improve hand strength and sensation patients more than one year post-injury.

HeartBeam plans to initiate an Early Access Program to gather feedback from patients and physicians prior to a commercial launch.

With remote control functionality, Liberty is designed to reduce radiation exposure for physicians and staff and improve ergonomics during procedures.

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.

Stone Clear is the first and only device cleared by the FDA that uses external ultrasound pulses to facilitate passage of post-lithotripsy kidney stone fragments without surgery.

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