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Innoblative Receives U.S. FDA Breakthrough Device Designation for its SIRA RFA Electrosurgical Device
Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA™ RFA Electrosurgical Device...
April 27, 2023
Imaging Visualization & Navigation
RapidAI Receives First and Only FDA 510(k) Clearance of Non-Contrast CT Imaging Product to Accelerate Acute Stroke Triage
RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA 510(k) clearance for Rapid NCCT Stroke – a major addition to the RapidAI suite of non-contrast based solutions for...
April 19, 2023
Imaging Visualization & Navigation
Precision Optics Appoints Mahesh Lawande as Chief Operating Officer
Precision Optics Corporation, Inc. (NASDAQ: POCI), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, today announced the appointment of medical device and aerospace/defense industry manufacturing veteran, Mahesh Lawande, as the Company’s Chief Operating Officer effective April...
April 17, 2023
Imaging Visualization & Navigation
SentiAR Announces Close of $8.5 million Series B Financing
SentiAR, Inc. a St. Louis, Missouri based pioneer in using Augmented Reality (AR) visualization technology for medical procedures, has closed an $8.5 million Series B financing.  The financing was led by cultivate (MD) Ventures and joined by MedVenture Partners alongside several insider investors, including TechWald...
April 13, 2023
Imaging Visualization & Navigation
FemDx Medsystems, Inc. Receives FDA Clearance For Its FalloView™ Falloposcope
FemDx Medsystems, Inc., a women’s health startup based in Santa Clara, CA announces the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FalloView™ device. According to Ashlee Francis, CEO of FemDx Medsystems, Inc., the device...
March 27, 2023
Imaging Visualization & Navigation
FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management
The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan®, the non-invasive liver management technology by Echosens. The update furthers FibroScan® accessibility to more people, enabling physicians to identify those at risk of suffering adverse...
March 22, 2023
Imaging Visualization & Navigation
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
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