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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
Imaging Visualization & Navigation
Siemens X-Ray System Gains FDA Clearance
Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the YSIO X.pree, a ceiling-mounted radiography system with the MyExam Companion intelligent user interface. In addition to this easy-to-use interface that guides the radiologic technologist through the exam...
October 27, 2020
Imaging Visualization & Navigation
Ezra Receives FDA Clearance for Prostate Cancer Artificial Intelligence
Ezra, the New York-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) clearance for its Artificial Intelligence designed to assist radiologists in analyzing and segmenting prostate MRI. Use of the innovative AI technology can...
October 20, 2020
Imaging Visualization & Navigation
FDA Grants GI Windows Medical Breakthrough Device Designation for Magnetic Anastomosis Technology
GI Windows Medical Corp, a clinical-stage, privately-held medical device company pioneering new advancements in anastomosis technology announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the self-forming magnetic compression anastomosis device indicated for small bowel...
October 1, 2020
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