Regulatory Approvals

Next Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief Using Each Patient's...

Phagenesis Ltd, announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Phagenyx® Neurostimulation System, a first-of-its-kind...

Life Spine announced that it received FDA 510(k) clearance for its Ghost 3D-printed titanium spacer system. Huntley, Illinois-based Life Spine’s Ghost 3D-printed titanium spacer expands on...

 Olive Diagnostics, an IoMT MedTech startup that uses AI for 100% passive urine analysis, announced that it has received the CE Mark in Europe for the...

Neosoma, Inc., an innovative medical technology company focused on helping clinicians advance the treatment of brain cancers, announced it has received U.S. Food...

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...

Duramesh combines implant incorporation in mesh repair with suture placement precision for the repair of soft tissues. Mesh Suture, which does business as MSi, has...

The company’s Seer Home device allows for potential epilepsy diagnosis through at-home data collection. Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG)...

Though drugs can help treat many cases of epilepsy, for the roughly 30% of patients with drug-resistant cases, it can take decades to find...