Regulatory Approvals

The US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based Watkins-Conti Products’ Yōni.Fit bladder support device as a temporary management of...

DentalMonitoring has secured De Novo approval from the US Food and Drug Administration (FDA) for its AI-powered remote orthodontic monitoring solution. The authorisation allows orthodontists...

UK-based artificial intelligence (AI) company, Brainomix, has seen its 360 e-Lung system granted market clearance from the US Food and Drug Administration (FDA) off...

FX Shoulder Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its full-wedge augmented glenoid baseplates. The newly cleared baseplates...

Baird Medical has received new Class III certificate for its ceramic thyroid ablation needle from China’s National Medical Products Administration (NMPA). The certificate recognises the...

US-based gynecologic medical devices company Meditrina has received the UKCA Mark and CE Mark approvals for its fully disposable Aveta Hysteroscopy System. Hysteroscopy is a...

Profound Medical announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer. Toronto-based Profound Medical develops and...

Early-stage medical device company Freyja Healthcare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VereSee device, used in...

OrthoXel announced that it received FDA 510(k) clearance for its Vertex hip fracture nail (HFN) for fracture fixation. The Cork, Ireland-based company says its nail...