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Imaging Visualization & Navigation

FDA Clears Fluidda’s Broncholab Platform for Use in Clinical Practice

The US Food and Drug Administration provided market clearance to Fluidda for its Broncholab platform. Broncholab provides a number of Functional Respiratory Imaging (FRI) parameters to physicians via an online platform to assist in diagnosing and monitoring of respiratory diseases....

March 12, 2020

Imaging Visualization & Navigation

NeuroPace RNS System Receives FDA Approval for MRI Labeling, Allowing Thousands More Patients to Benefit from Personalized, Data-Driven Epilepsy Treatment 

NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced that its RNS® System has received U.S. Food and Drug Administration (FDA) approval of MRI labeling for the RNS System, expanding treatment options for the approximately one million patients in the...

March 11, 2020

Imaging Visualization & Navigation

Nanox Signs Agreement With The Gateway Group for the Deployment of 1,000 Nanox.ARC Units Across Australia, New Zealand, and Norway 

NANO-X IMAGING LTD (www.nanox.vision) (“Nanox” or the “Company”), an innovative medical imaging technology company, announces it has secured an exclusive distribution deal with The Gateway Group (“Gateway”), one of Australia’s largest independent product distributors including health, wellness, medical supplies and devices. The agreement...

March 2, 2020

Imaging Visualization & Navigation

Arizona Startup Emagine Solutions Technology Receives FDA 510(k) Clearance of its VistaScan Mobile Ultrasound

Emagine Solutions Technology, an award-winning medical software device company located in Tucson, announced that it has received clearance from the U.S. Food & Drug Administration (“FDA”) to market its VistaScan mobile ultrasound platform. The VistaScan platform transforms a clinician’s cell phone...

February 27, 2020

Imaging Visualization & Navigation

WaveGuide Launches World’s First Portable NMR Device: the WaveGuide Formµla 

WaveGuide Corporation, an innovator of portable micro NMR (Nuclear Magnetic Resonance) instruments, today launched its new WaveGuide Formµla™, the world’s only battery-powered, compact scientific instrument that performs rapid screening and diagnostics of solid and liquid substances spanning an array of...

February 26, 2020

Imaging Visualization & Navigation

Compumedics Announces Milestone US FDA Approval for the Orion Lifespan MEG 

Compumedics Limited is pleased to announce that on February 14, 2020, it received 510(K) clearance from the US Food and Drug Administration (FDA) for its Orion LifeSpan™ Magnetoencephalography (MEG) single Dewar system. This news follows the successful installation and first phase...

February 19, 2020

Imaging Visualization & Navigation

World’s First Bedside MRI System Receives FDA 510(k) Clearance 

Hyperfine Research, Inc. announced today that it has received US Food & Drug Administration 510(k) clearance for the world’s first bedside Magnetic Resonance Imaging (MRI) system, clearing the way for device shipments this summer. The Hyperfine system is 20X lower...

February 12, 2020

Imaging Visualization & Navigation

PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear 

PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing physicians with better diagnostic tools, today announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for its TOMi™ Scope for non-invasive imaging of the middle ear. Using...

January 6, 2020

Imaging Visualization & Navigation

Google AI Tool Bests Clinicians in Breast Cancer Detection Study 

A Google artificial intelligence tool may predict breast cancer better than doctors, according to a study published Wednesday in the journal Nature. The algorithm, which was trained on almost 91,000 mammogram scans from women in the U.S. and U.K., resulted in almost...

January 3, 2020