Regulatory Approvals

EDAP wins FDA nod for its Focal One robotic high-intensity focused ultrasound system

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...

Neurolyser XR now FDA cleared for sale in USA

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

FDA clears Levita’s Magnetic Surgical System for pediatric use

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 secures FDA approval for ROSA Knee with OptimiZe system

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 unveils Yomi S: its next-gen AI-powered dental robot

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 wins expanded FDA indications for spinal cord stimulation at home

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)...

FDA clears Augmedics’ AR headset for use with spine surgery system

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...

FDA clears ViTAA Medical’s AI aortic surgery planning tool

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...

FDA and EU clear Zap Surgical’s radiosurgery planning system

Zap Surgical’s ZAP Axon radiosurgery planning system has received 510(k) clearance from the US Food and Drug Administration (FDA), as well as gaining the...
1...121314...116Page 13 of 116

Latest articles