Regulatory Approvals

Paradromics received FDA investigational device exemption (IDE) to begin a study of its brain-computer interface (BCI). The FDA nod enables the company to start...

EDAP TMS SA announced that the FDA granted 510(k) clearance for new workflows for its ultrasound technology. The new ultrasound imaging and workflow enhancements...

FUSMobile announced that it received De Novo marketing authorization (DEN250015) from the FDA to begin marketing and sales of the Neurolyser XR system for...

Levita Magnetics has received FDA 510(k) clearance for its Magnetic Surgical System (MSS) to be used in certain pediatric surgeries, with the first U.S....

Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe technology. It is an updated version...

Neocis launched Yomi S, its next-generation robotic platform for dental implant surgery. Miami-based Neocis designed Yomi S, powered by the YomiPlan AI software, to...

Onward Medical announced today that it received FDA 510(k) clearance to expand the ARC-EX system’s indication for home use. ARC-EX spinal cord stimulation (SCS)...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Augmedics’ new augmented reality (AR) headset, X2, designed for use with the...

ViTAA Medical’s aortic surgery planning tool has gained clearance from the US Food and Drug Administration (FDA), representing the first milestone in the company’s...