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FDA Clearance Brings RefleXion Closer to Expanding Cancer Treatment Market 
RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* to treat all stages of cancer today announced it has received marketing clearance from the U.S. Food & Drug Administration (FDA) for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery...
March 18, 2020
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 ( (“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
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