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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
Imaging Visualization & Navigation
Waters Takes Targeted, Quantitative Imaging to the Next Level with New DESI Source for the Xevo TQ Absolute System
American Society for Mass Spectrometry (ASMS) — Waters Corporation (NYSE:WAT) today launched the industry’s first targeted imaging mass spectrometer based on its Xevo™ TQ Absolute tandem quadrupole mass spectrometer, the most sensitive and compact mass spectrometer in its class. The new instrument combines the Waters™ DESI...
June 5, 2023
Imaging Visualization & Navigation
Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System
Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The Orlucent system is a handheld point-of-care...
May 22, 2023
Imaging Visualization & Navigation
Koning Sees Surge in Orders Following Recent Installations at Prominent Hospitals and Attendance at the Society of Breast Imaging Symposium
Koning Corporation, the leading manufacturer of breast computed tomography (CT) systems, announced today that it has received the largest pipeline of orders in its history. The company has seen a surge in demand for its innovative Koning Vera Breast CT...
May 16, 2023
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