Moon Surgical received FDA clearance for the commercial version of its Maestro surgical robot system. The Paris-based company designed Maestro to provide an accessible,...
Pre-clinical medical device company Microbot Medical has obtained US Food and Drug Administration (FDA) approval to proceed with its pivotal human clinical trial for...
Zeto announced received FDA 510(k) clearance for its One product for electroencephalography (EEG) brain monitoring. Santa Clara, California-based Zeto designed One to feature a...
Medical technology company InnoVoyce’s VYLO Laser System has received 510(k) clearance from the US Food and Drug Administration (FDA).
The VYLO Laser System, a 455nm...
Canary Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its smart spine device, Canturio Lumbar Cartridge (canturio...
The US Food and Drug Administration (FDA) has granted clearance to Spineart for its Scarlet AC-Ti anterior cervical cage. Cages are interbody devices used...
Galvanize announced the FDA granted 510(k) clearance for its Inumi Flex endoscopic needle with the Aliya system for soft tissue ablation.
Inumi Flex expands the...
CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app.CamAPS FX, an Android app, received approval...
Stereotaxis announced today that it received CE mark for its devices in Europe under new European Medical Device Regulation framework. Recertification under MDR covers...
