Regulatory Approvals

Abiomed (Nasdaq:ABMD) announced that it received FDA 510(k) clearance for its Impella low-profile sheath. Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner...

The Flux-C 3D porous titanium devices are available in several parallel and lordotic options with different heights. ulrich medical USA has secured 510(k) clearance from the US...

XACT Robotics® has announced that its ACE Xtend™ Remote Control Unit received U.S. Food and Drug Administration (FDA) clearance, allowing users to robotically insert and...

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,...