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FDA Approval

First Fully Immersive 3D Augmented Reality Surgical Navigation System Achieves FDA Approval for Precision Spine Surgery

VisAR, an augmented reality surgical navigation system from healthcare technology leader Novarad, receives FDA 510(k) approval for precision guided intraoperative spine surgery. VisAR transforms...

MEDICALGORITHMICS Secured FDA Approval for Qpatch Wearable

Qpatch is a state-of-the-art wearable device for measuring individual ECG signal to obtain accurate cardiac arrhythmia diagnosis across many days. It allows ECG monitoring...

Medtronic Receives FDA Approval for Interstim X System

Medtronic plc, a global leader in healthcare technology, announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ―...

Abbott’s CardioMEMS™ HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the company's CardioMEMS™ HF System to support the...

Denovo Biopharma LLC Announces FDA Approval of IND to Initiate First Biomarker-Guided Global CNS Clinical Trial for TRD

Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to the development of innovative therapies, announced that the FDA has authorized the company's...
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