Regulatory Approvals

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, 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...

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...

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

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