medical device guru

Imaging Visualization & Navigation
FDA Clearance for Artificial Intelligence Upgrade to Ninepoint’s Imaging System
NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time imaging platform for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its Intelligent Real-time Image Segmentation™ (IRIS)...
November 6, 2018
Imaging Visualization & Navigation
Novarad Lands FDA Clearance for its HoloLens-augmented Preoperative System
The possibilities of Microsoft’s HoloLens system have become a hot topic in the medical world in recent years. But last week Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company’s augmented reality headset. The newly FDA-cleared system...
October 30, 2018
Imaging Visualization & Navigation
Carestream digital x-ray system installed at remote Antarctic research station
A Carestream digital x-ray system has been installed at the Italian-French Concordia station in Antarctica, on a 10,500-foot mountain 620 miles from the coast. The station was first built to support the European Project for Ice Coring in Antarctica, but...
October 3, 2018
Imaging Visualization & Navigation
FDA Clears Leica’s Augmented Reality Neurosurgical Visualization Solution
Last week, Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration to market its augmented reality GLOW800 surgical fluorescence for vascular neurosurgery. In combination with ICG (Indocyanine Green), GLOW800 allows surgeons to observe cerebral anatomy in natural...
September 26, 2018
Imaging Visualization & Navigation
INSIGHTEC Receives FDA Approval for Exablate Neuro Compatibility with Siemens Healthineers MRI Scanners
INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration has approved Exablate Neuro™ compatibility for the state-of-the-art MRI Scanners Magnetom Skyra, Prisma and Prismafit from Siemens Healthineers to treat patients with essential tremor. “This important milestone is...
September 26, 2018
Imaging Visualization & Navigation
Heidelberg Engineering wins FDA nod for OCT Angiography Module
The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is...
September 20, 2018
Imaging Visualization & Navigation
FDA Clears UVision360 Office Hysteroscopy Device
Luminelle DTx Hysteroscopy System has received its 510(k) clearance from the FDA with a dual-indication for both hysteroscopy and cystoscopy.  The Luminelle DTx Hysteroscopy System is small, easy to use, cost effective and has the potential for an affordable, accurate...
August 22, 2018
Imaging Visualization & Navigation
Orange County to Use First CT Scanner for Autopsies in Florida
Florida’s Orange County is investing half a million dollars in a CT scanner for its local morgue, a move expected to speed up the autopsy process and facilitate criminal investigations without cutting into victims’ bodies, WFTV reported this week. The...
August 6, 2018
Imaging Visualization & Navigation
First Ever Color X-Ray Performed on a Human
What if, instead of a black and white X-ray picture, a doctor of a cancer patient had access to colour images identifying the tissues being scanned? This colour X-ray imaging technique could produce clearer and more accurate pictures and help...
July 12, 2018
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