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Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT™ Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). LUMISIGHT...

March 21, 2023

Imaging Visualization & Navigation

SpectraWAVE Secures 510(k) Clearance of HyperVue™ Intravascular Imaging System

SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue™. The system combines next-generation...

March 1, 2023

Imaging Visualization & Navigation

Hyperfine, Inc. Announces FDA Clearance for Improved AI-Powered Software and Expanded Field of View for the Swoop® Portable MR Imaging® System

Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch...

February 13, 2023

Imaging Visualization & Navigation

2,000 AI-Driven, Intraoperative CT-Guided Procedures Completed with LungVision

Body Vision Medical, a leader in AI-driven, intraoperative imaging, announced that its LungVision™ AI-driven, intraoperative CT imaging system has now been used in 2,000 diagnostic bronchoscopy procedures worldwide. Body Vision Medical’s LungVision™ System uses artificial intelligence (AI) to transform X-ray images from...

December 14, 2022

Imaging Visualization & Navigation

Desert Imaging Deploys densitas® intelliMammo™ A.I. Solutions for Breast Screening Services

Densitas® Inc., a global provider of A.I. solutions for digital mammography and breast screening announced that Desert Imaging has implemented the densitas® IntelliMammo™ platform across their health system. The adoption of intelliMammo™ reinforces Desert Imaging’s established commitment to maintaining robust organization-wide...

November 29, 2022

Imaging Visualization & Navigation

NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced that its head-to-toe trauma imaging solution, the BodyTom® 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, has received 510(k) clearance from the U.S. Food and Drug Administration for commercial use in...

November 28, 2022

Imaging Visualization & Navigation

Body Vision Medical Accelerates International Expansion with Business Asia Consultants, Inc., Partnership

Body Vision Medical, a leader in AI-driven, intraoperative imaging, announced a new partnership with Business Asia Consultants (BAC), Inc. as part of its international expansion strategy.  BAC will apply its extensive European, Asian and Latin American market development expertise to...

October 6, 2022

Imaging Visualization & Navigation

FDA Grants QT Imaging™ Clearance to Calculate Fibroglandular Volume of the Breast

The U.S. Food and Drug Administration (FDA) has granted QT Imaging, Inc. 510(K) clearance to calculate the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV). This ratio can contribute to an assessment...

September 22, 2022

Imaging Visualization & Navigation

Caption Health Receives CE Mark for Caption AI™ Technology Platform

Caption Health, the leader in using AI and services to improve heart ultrasound access, announced that it has received a CE Mark for its Caption AI™ technology platform. This certification represents the first step in making Caption Health’s industry-leading technology...

July 19, 2022