Regulatory Approvals

Paige, a leader in next-generation AI technology, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect,...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for restor3d’s cementless iTotal Identity CR 3DP Porous Total Knee Replacement System. The company...

Bright Uro received FDA 510(k) clearance for its Glean urodynamic analyser system. Glean, a comprehensive system, enables wireless, catheter-free urodynamics. Bright Uro aims to provide...

The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants...

Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA). This designation is significant not...

MedCAD has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AccuStride Foot and Ankle System. This clearance permits the company...

Enable Injections’ enFuse Syringe Transfer System has secured CE mark approval under the European Union Medical Device Regulation (EU MDR). This approval allows the company...

SiBionics unveiled its GS3 continuous glucose monitor (CGM), which now has CE mark approval. The company unveiled the device — which it touts as...

The US Food and Drug Administration (FDA) has cleared Vent Creativity’s Hermes Knee, an AI-driven software solution for knee arthroplasty procedures. The solution uses deep...