CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app.CamAPS FX, an Android app, received approval...
Stereotaxis announced today that it received CE mark for its devices in Europe under new European Medical Device Regulation framework. Recertification under MDR covers...
Indica Labs has received 510(k) clearance from the US Food and Drug Administration (FDA) for its enterprise digital pathology platform, HALO AP Dx.
This approval...
AngioDynamics announced it received CE Mark approval for its AlphaVac F18 system, which treats pulmonary embolism and removes thrombi and emboli. AlphaVac F18 is...
Medical technology company Axonics has announced receipt of Australia’s Therapeutic Goods Administration’s (TGA) approval for its Axonics F15 recharge-free sacral neuromodulation (SNM) system.
Designed to...
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...
