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Tag: Regulatory Approval

Adagio Medical wins FDA IDE to expand ventricular ablation study

Adagio Medical wins FDA IDE to expand ventricular ablation study

Anumana receives FDA clearance for ECG-AI Cardiac Amyloidosis algorithm, using a standard 12-Lead ECG

Anumana receives FDA clearance for ECG-AI Cardiac Amyloidosis algorithm, using a...

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System...

Serenity Medical earns FDA HDE for cerebral venous stent

Serenity Medical earns FDA HDE for cerebral venous stent

Medtronic wins CE mark for OmniaSecure pacemaker lead

Medtronic wins CE mark for OmniaSecure pacemaker lead

Anumana secures FDA clearance for ECG-AI algorithm

Anumana secures FDA clearance for ECG-AI algorithm

Neurovalens receives EU MDR compliance for sleep insomnia device

Neurovalens receives EU MDR compliance for sleep insomnia device

4DMedical receives CE Mark for CT:VQ, enabling commercial launch across the EU

4DMedical receives CE Mark for CT:VQ, enabling EU launch

Pixee Medical announces CE Mark for Knee+ NexSight

Pixee Medical announces CE Mark for Knee+ NexSight

Meril secures CE mark for MISSO Surgical Robot

Meril secures CE mark for MISSO Surgical Robot

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