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 the European market and additional global regions. The 7D Surgical MvIGS System is the only…

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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,” said Dee Kolanek, INSIGHTEC Vice President of Reimbursement. “The efforts of our team have made complete…

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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 labeling nodules of different types. InferRead Lung CT.AI is designed to support concurrent reading and…

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Arterys Raises $28 Million to Accelerate the Delivery of Medical AI to Practices Around the World

Arterys Logo

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 by Benslie Investment Group and Temasek Holdings, with participation by Fosun, Revelation Partners, Emergent Medical…

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Philips Receives FDA Clearance for the Use of its Ultrasound Portfolio to Manage COVID-19-Related Complications

Ultrasound Philips

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 cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians…

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Butterfly Network, Inc. is Bringing Ultrasound into the Home with Telemedicine

Butterfly Network Ultrasound Telemedicine

Butterfly Network has developed and is rolling out a new version of TeleGuidance™, their ultrasound-based telemedicine platform. TeleGuidance brings medical imaging to telemedicine. It leverages an array of leading-edge and easy-to-use augmented reality guiding tools. It allows trained practitioners to perform an ultrasound scan without being next to the patient. “We are grateful for the…

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FDA Approves Aspenstate’s AiRTouch Portable X-Ray System for Human Medical Use

Aspenstate In AiRTouch

Aspenstate has received clearance for their portable x-ray system, AiRTouch, from the U.S. Food and Drug Administration (FDA). Amongst many applications, this device is a simple and efficient front-line tool to acquire chest x-rays to diagnose COVID-19. The AiRTouch device offers a unique list of capabilities in the battle against COVID-19. It’s lightweight (5.5 lbs),…

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Centerline Biomedical Completes First Human Patient in the United States with IOPS (Intra-Operative Positioning System)

Centerline Imaging

Surgical navigation startup Centerline Biomedical, Inc. (Centerline), a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series clinical cases in the United States as it begins limited launch of its innovative IOPS™ technology platform. The FDA-cleared technology is being deployed at Cleveland Clinic to begin, with other leading intuitions to follow,…

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Synaptive Medical Secures FDA Clearance for Evry

evry

Synaptive Medical, a leader in robotic surgical visualization, announced today the company has secured clearance from the Food and Drug Administration (FDA) for its superconducting, head magnetic resonance imaging (MRI) technology, Evry™. Synaptive developed Evry to provide medical professionals with diagnostic imaging capabilities directly at the point of care in critical care settings, which was…

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Olympus Launches EVIS X1, its Most Advanced Endoscopy System to Date

Olympus_EVIS-X1_CV-1500_front_72dpi

Olympus Corporation (President: Yasuo Takeuchi) today announced the launch of EVIS X1, its most advanced endoscopy system to date. The new system is to improve outcomes from disorders of the stomach, colon, and oesophagus, as well as from bronchial diseases, by providing every endoscopist with innovative and proven tools. The launch of EVIS X1 further…

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