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Imaging Visualization & Navigation

HistoSonics Notches Significant Reimbursement Wins

HistoSonics, (www.histosonics.com), the manufacturer of the non-invasive Edison® Histotripsy System and novel sonic beam therapy, announced today that the Centers of Medicare & Medicaid Services (CMS) set a new payment rate for histotripsy of liver tumors procedures, increasing the payment...

November 6, 2023

Imaging Visualization & Navigation

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for...

October 9, 2023

Imaging Visualization & Navigation

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved MRI conditional...

September 26, 2023

Imaging Visualization & Navigation

SpectraWAVE Secures 510(k) Clearance to Add Saline Imaging and Expanded Artificial Intelligence Features to the HyperVue™ Imaging System

SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue™ Imaging System. The intravascular...

September 20, 2023

Imaging Visualization & Navigation

Zeta Surgical’s Mixed Reality Navigation System Receives FDA Clearance

Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S. Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. The Zeta Cranial Navigation System is a mixed-reality navigation...

September 11, 2023

Imaging Visualization & Navigation

Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software

Techsomed Ltd., a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO software intended to assist physicians in planning...

September 5, 2023

Imaging Visualization & Navigation

Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. This achievement is the second...

July 31, 2023

Imaging Visualization & Navigation

RIVANNA receives $30.5 million from BARDA to advance the Accuro XV musculoskeletal imaging system

RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response...

July 28, 2023

Imaging Visualization & Navigation

MediView Receives FDA 510(k) Clearance for XR90 Augmented Reality-Based Visualization and Navigation Platform

MediView XR, Inc., a leading clinical augmented reality med-tech company, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for its XR90 augmented reality-based surgical visualization and navigation platform. XR90 is intended to be used...

July 20, 2023