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 color, augmented by real-time vascular flow in a single image, with full depth perception. This…

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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 directly attributed to the commitment and collaboration of the teams at INSIGHTEC and Siemens Healthineers,…

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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 a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses…

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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 patient diagnosis and/or therapeutic procedure in one doctor’s office visit. The system went from concept…

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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 CT machine county officials have their eyes on is one currently being used in fewer…

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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 doctors give their patients more accurate diagnoses. This is now a reality, thanks to a…

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Imaging Group MITA Warns China Tariffs Will Cost $138M to US Imaging Industry

The Medical Imaging and Technology Alliance (MITA) – the leading organization and collective voice of medical imaging equipment, radiopharmaceutical manufacturers, innovators, and product developers – today called on the Trump Administration to establish a timely and robust exemption process for medical imaging products and components from China Section 301 tariffs, which went into effect today.…

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Florida Hospital First in State to Adopt BodyTom Elite, Samsung’s Updated CT Scanner

DANVERS, MA, June 7, 2018 – NeuroLogica, a subsidiary of Samsung Electronics Co., Ltd., a leader in medical imaging technology, announced today that Florida Hospital in Orlando, Fl., added the BodyTom® Elite, the newly upgraded, portable, 32-slice computed tomography scanner, to their brachytherapy suite. The BodyTom Elite improves the patient experience, patient safety and workflow efficiency by…

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Mauna Kea Cellvizio Laser Receives Expanded Clearance for Neurological Procedures

Mauna Kea‘s (Paris, France) Cellvizio 100 series F400 and F800, with a new Confocal Miniprobe called CranioFle, has been granted FDA clearance to be used in neurological procedures targeting brain and spinal tumors. The confocal laser endomicroscopy system allows clinicians to analyze the cellular structure and characteristics of tissues right in the operating room. The…

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New “Ultrasound on a Chip” Tool Could Revolutionize Medical Imaging

Medical Imaging

Jonathan Rothberg, a entrepreneur who prides himself on drastically disrupting the biomedical industry every so often, has typically big claims for his new product. The Butterfly iQ, a cheap handheld ultrasound tool with AI smarts tucked inside, will 1) revolutionize medical imaging in hospitals and clinics, 2) change the game in global health, and 3) eventually…

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