Regulatory Approvals

FDA clears CapsoVision capsule endoscopy tech for pediatric patients

CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above. The CapsoCam Plus system...

neuroClues secures CE certification for its eye-tracking technology set to enhance neurologic care

neuroClues, a European MedTech company specialising in the diagnosis of neurodegenerative diseases, received the MDR certificate for its groundbreaking eye-tracking device. Innovation in the EU...

The FDA clears Magstim Horizon INSPIRE TMS system

Magstim won U.S. Food and Drug Administration (FDA) clearance for the Horizon Inspire System, which provides physicians, nurse practitioners, clinicians, and researchers with next-generation...

FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

Roivios, a pioneering clinical-stage medical device company dedicated to revolutionising kidney health, announced its research and development arm, 3ive Labs, has secured approval for...

Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system

Onward Medical received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously...

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

HeartBeam has gained the US Food and Drug Administration’s 510(k) clearance for its comprehensive arrhythmia assessment system. The patented high-fidelity electrocardiogram (ECG) HeartBeam device, distinguished...

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

Cercare Medical announced FDA clearance for its CT perfusion imaging software, a significant milestone that complements the existing clearance for MRI perfusion imaging. This...

Liquet Medical receives FDA 510(k) clearance for the Versus catheter

Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received 510(k) clearance from...

FemPulse wins FDA IDE for for overactive bladder neuromod

FemPulse received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB) therapy. The company can now begin the EVANESCE II pivotal clinical trial...
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