Regulatory Approvals

Penumbra, a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial availability of the...

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction,...

Innovative System Will Expand Oticon Medical’s Proven Expertise in Cochlear Implantation to US Market Oticon Medical today announced that the US Food and Drug Administration...

The VisionPort™ is the first surgeon-controlled, multi-camera laparoscopic visualization system New View Surgical, Inc., a medical device company developing proprietary imaging and access technologies for...

Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical...

While most options for chronic pain relief rely on either invasive implanted devices or opioids and other highly addictive drugs, NeuraLace Medical’s entry in...

Elekta Harmony linear accelerator cleared by U.S. Food and Drug Administration Elekta (EKTA-B.ST) announced todaythat its Elekta Harmony* radiation therapy system recently received U.S. FDA...

ONWARD announced the Company has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for their ARC-IM platform for blood...

LivaNova is developing the aura6000 System to treat obstructive sleep apnea. The device will be evaluated in the OSPREY RCT Trial. The study comes...