Regulatory Approvals

Sensydia, an innovator in rapid, non-invasive measurement of critical cardiac function, announced that its Cardiac Performance System (CPSTM) has been granted Breakthrough Device Designation by the United States...

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...