Regulatory Approvals

CeriBell announced that it received FDA 510(k) clearance for its next-generation Clarity algorithm. The new algorithm detects electrographic seizures in newborns pre-term and older. Clearance...

QuantalX Neuroscience’s Delphi-MD, a device to monitor and evaluate brain health, has gained de novo classification from the US Food and Drug Administration (FDA),...

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)...