Regulatory Approvals

Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

The neurostimulation device, which is currently for investigational use only, aims to treat cognitive and functional decline in Alzheimer's patients. Cambridge-based Sinaptica Therapeutics, a company...

Medtronic’s Hugo surgical robot collects green lights in Europe, Canada, Japan

Hugo is going on a whirlwind international tour. Medtronic’s modular surgical robot has received a series of new regulatory approvals the company says will greatly expand...

FDA clears Impella low-profile sheath from Abiomed

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...

ulrich medical’s cervical interbody device secures FDA 510(k) clearance

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® Wins FDA Clearance for ACE Xtend™ Remote Control Unit

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...

Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain

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 Launches Phagenyx Neurostimulation System in the U.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...

FDA clears 3D-printed titanium spacer from Life Spine

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 Receives European CE Mark for its Cutting Edge AI-based Urine Analysis 

 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...
1...798081...114Page 80 of 114

Latest articles