Regulatory Approvals

Inspan LLC has announced that it has received US Food and Drug Administration (FDA) clearance for its interspinous plate fixation device to be used...

Abbott has received clearance from the US Food and Drug Administration (FDA) for the EnSite X EP system with EnSite Omnipolar Technology (OT), a...

Medical device and technology company Lazurite Holdings LLC announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA)...

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal...

Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal...

Manus Neurodynamica, which develops and markets products and technologies for neuromotor assessment, has been granted Breakthrough Designation by the U.S. Food and Drug Administration (FDA) for...

Implicity has announced US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyses ECG data from implantable loop recorders (ILRs). “This...

ClaroNav Kolahi Inc, a subsidiary of ClaroNav Inc, has received Chinese regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its...

Intuitive (Nasdaq: ISRG) has today announced that the U.S. Food & Drug Administration (FDA) cleared the company’s fully wristed, 8 mm SureForm 30 Curved-Tip Stapler and reloads...