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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
Imaging Visualization & Navigation
7D Surgical Wins CE Mark Certification for Machine Vision Image Guided Spine Surgery
7D Surgical announced today that it has achieved CE Mark certification for its innovative Machine-vision Image Guided Surgery (MvIGS) system for spine surgery. This achievement clears the way for 7D Surgical to commence commercialization efforts of its spinal platform across...
July 16, 2020
Imaging Visualization & Navigation
INSIGHTEC wins Medicare Coverage for MR-Guided Focused Ultrasound Platform
INSIGHTEC, a global medical technology innovator of incisionless surgery, announced today achievement of complete Medicare coverage across all 50 states for MR-guided focused ultrasound treatment of medication-refractory Essential Tremor. “INSIGHTEC is committed to expanding patient access for MR-guided focused ultrasound,”...
July 13, 2020
Imaging Visualization & Navigation
FDA Green-lights Infervision’s Deep Learning Tool for Segmenting Lung CT Scans
Infervision is pleased to announce the U.S. Food and Drug Administration (FDA) 510(K) clearance of the InferRead Lung CT.AI product, which uses the state-of-the-art artificial intelligence and deep learning technology to automatically perform lung segmentation, along with accurately identifying and...
July 10, 2020
Imaging Visualization & Navigation
Arterys Raises $28 Million to Accelerate the Delivery of Medical AI to Practices Around the World
Arterys, a leading global medical imaging platform to deliver clinical AI products over the internet, just received its seventh USA FDA clearance and announced its latest round of funding — a $28 million Series C investment from a syndicate led...
June 2, 2020
Imaging Visualization & Navigation
Philips Receives FDA Clearance for the Use of its Ultrasound Portfolio to Manage COVID-19-Related Complications
Royal Philips, a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and...
May 21, 2020
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