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Latest iCad 3D Mammography AI Gains CE Mark
iCAD, Inc., a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis (DBT) received CE Mark approval. Compared to previous software versions, the latest generation of ProFound AI...
June 20, 2021
Imaging Visualization & Navigation
Activ Surgical Announces FDA Clearance for ActivSight Enhanced Surgical Visualization Device
Activ Surgical, a digital surgery pioneer, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The hardware agnostic imaging module has been designed to provide surgeons real-time intraoperative...
April 11, 2021
Imaging Visualization & Navigation
Quibim Receives FDA 510(k) Clearance for qp-Prostate AI Solution for Prostate MRI Analysis
Quibim, a global leader in whole-body medical imaging analysis, announced today the launch of qp-Prostate, its latest and most advanced prostate AI based Magnetic Resonance (MR) solution, after receiving 510(k) clearance by the US Food and Drug Administration. The solution aids...
March 14, 2021
Imaging Visualization & Navigation
ZAP Surgical Receives CE Mark Clearance for its ZAP-X Gyroscopic Radiosurgery Platform
ZAP Surgical Systems, Inc. today announced it has received CE mark clearance to the new EU MDR for its ZAP-X® Gyroscopic Radiosurgery® platform. The CE mark makes it possible for healthcare providers to begin treating patients with the ZAP-X system...
February 7, 2021
Imaging Visualization & Navigation
FDA Clears MULTIX Impact C Ceiling-Mounted DR System
Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system. Economically priced,...
January 30, 2021
Imaging Visualization & Navigation
FDA Approves Seno Medical’s Breast Lesion Diagnostic Technology
The Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments, Inc. (Seno) premarket approval (PMA) for its groundbreaking diagnostic breast cancer imaging technology that helps physicians better differentiate...
January 20, 2021
Imaging Visualization & Navigation
FDA Clears Siemens’ Cios Flow Mobile C-arm System
Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Cios Flow, a mobile C-arm designed for use by multiple disciplines in the operating room (OR) – including orthopedics, trauma surgery, spinal surgery, vascular surgery, and pain...
January 18, 2021
Imaging Visualization & Navigation
Hologic to Acquire Somatex Biopsy Site Marker Technology for $64 Million
Hologic (NSDQ:HOLX) announced today that it completed the acquisition of Somatex Medical Technologies GmbH for $64 million. Marlborough, Mass.-based Hologic’s acquisition of the company, which was previously owned by E-Med Solutions GmbH, is slated to support its strategy of providing further solutions across...
January 4, 2021
Imaging Visualization & Navigation
Philips and Insightec Teaming Up on Ultrasound for Neurosurgery
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology and InSightec, a global healthcare company focused on the therapeutic power of acoustic energy, today announced a collaboration to expand access to MR-guided focused ultrasound for incisionless neurosurgery. By developing...
December 21, 2020
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