medical device guru

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
Imaging Visualization & Navigation
FDA Allows At-Home Administration for CapsoVision Capsule Endoscope
CapsoVision, an innovator in the gastroenterology diagnostics market, today announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who...
September 28, 2020
Imaging Visualization & Navigation
NOUS Imaging Receives 510(k) Clearance from FDA for Real Time MRI Software
NOUS Imaging, a medical imaging software company, today announced that the FDA has cleared its 510(k) submission for FIRMM, Framewise Integrated Real-Time MRI Monitoring. FIRMM provides real-time monitoring and biofeedback that addresses the significant problem of patient motion during brain...
September 25, 2020
Imaging Visualization & Navigation
Fujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for Point-of-Care Ultrasound Portfolio
FUJIFILM Sonosite, Inc., specialists in developing cutting-edge point-of-care ultrasound (POCUS) solutions, and part of the larger Fujifilm Healthcare portfolio, today announced that the company has received 510(k) Clearance from the U.S. Food & Drug Administration (FDA) for the company’s entire POCUS portfolio...
September 8, 2020
Imaging Visualization & Navigation
Hyperfine Receives FDA 510(k) Clearance for Portable MRI System
Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its category-defining portable MRI technology, the Swoop™ Portable MR imaging device. Hyperfine’s Swoop™ system is a point-of-care MR imaging device that wheels directly to the patient’s bedside, plugs into...
August 20, 2020
Imaging Visualization & Navigation
Siemens Healthineers to buy Varian Medical Systems for $16.4 billion
Varian today announced that it has entered into a definitive agreement to combine with Siemens Healthineers AG in an all-cash transaction valued at $16.4 billion on a fully diluted basis. Under the terms of the agreement, which has been unanimously...
August 3, 2020
Imaging Visualization & Navigation
FDA Clears Zebra Medical’s Breast Cancer AI for Spotting Suspicious Mammography Lesions
Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by prioritizing and identifying suspicious mammograms,...
July 28, 2020
1 2 3 15