Regulatory Approvals

FDA clears redesigned kidney stone treatment tech from Calyxo

Calyxo announced today that it received FDA clearance for its new, redesigned CVAC system for minimally invasive kidney stone treatment.Pleasanton, California–based Calyxo’s CVAC system...

FDA clears Neuronetics’ neurostim for adolescents with depression

Neuronetics announced that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as...

Health Canada approves Innodem Neurosciences’s Eye-Tracking Neurological Assessment for Multiple Sclerosis

Health Canada has granted approval of the Eye-Tracking Neurological Assessment for Multiple Sclerosis (ETNA™-MS). Developed by Innodem Neurosciences (Innodem), ETNA™-MS is a software as...

RedDrop Dx wins FDA approval for RedDrop One blood collection device

US-based medical equipment manufacturer RedDrop Dx has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced blood collection device, RedDrop...

Elixir Medical wins FDA breakthrough designation for DynamX BTK implant

Elixir Medical today announced it received FDA breakthrough device designation for its DynamX BTK system for treating chronic limb-threatening ischemia. The Milpitas, California-based company...

Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year

Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.The company obtained European Union Medical Device Regulation...

inHEART Receives FDA Clearance for Advanced AI-driven Software Module That Optimizes the Creation of 3D Models of the Heart

inHEART, a privately-held medical device company delivering the world's most advanced, AI-driven digital twin of the heart, announced today that it has received FDA...

FDA clears Ventris Medical Amplify standalone bone graft putty

Ventris Medical recently received FDA 510(k) clearance for its Amplify standalone bone graft putty in the intervertebral disc space. The Newport Beach, California-based company designed...

Cosm Medical wins FDA clearance for personalised Gynethotics pessaries

The US Food and Drug Administration (FDA) has granted clearance to Cosm Medical for its Gynethotics Pessaries for pelvic floor disorders. The current gold standard...
1...515253...113Page 52 of 113

Latest articles