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Onkos Surgical Receives FDA 510(k) Clearance for 3D Printed, Patient-Specific Pelvic Reconstruction System

Onkos Surgical, a rapidly growing, leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, announced that it has received 510(k) clearance for...

FDA Clears DyAnsys Neurostimulation Device First Relief to treat Diabetic Neuropathic Pain

First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US Food and Drug Administration for multiple treatments up to 56...

Medtronic Receives FDA Clearance for Next-Generation UNiD Spine Analyzer

Medtronic plc, a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UNiD...

VisAR Augmented Reality Surgical Guidance System Using Low-Cost Off-the-Shelf HoloLens 2 Hardware Achieves Results in Spine Surgery

Novarad announced the publication of the article Augmented Reality Spine Surgery Navigation: Increasing Pedicle Screw Insertion Accuracy for Both Open and Minimally Invasive Spine...

MCRA Assists NeuroMetrix with obtaining FDA Breakthrough Device Designation and Marketing Authorization

MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare...
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