Regulatory Approvals

Real-time Image Processing Enables Software-Only Guidance and Verification in Minimally Invasive Spine Surgery. VUZE Medical, a privately held medical technology company aimed at transforming image...

MicroPort CRM, a pioneering company in the field of Cardiac Rhythm Management, headquartered in France, has recently received the pharmaceuticals and medical devices agency...

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...