The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II. Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any […]
Medtronic issues urgent field safety notice for O-arm imaging system
Medtronic (NYSE:MDT) announced that it determined that a replacement of the internal gantry tractor motor drive will resolve an issue with the O-arm O2 imaging system that the company warned customers of last year. In November, Medtronic notified customers of the potential for navigational inaccuracy with the O-arm O2 system’s auto-registration feature when used in conjunction […]
Nanox Imaging raises $26m
Nanox Imaging announced today that it secured $26 million in funding in support of the development, commercialization and deployment of its Nanox System for early detection of medical conditions. With participation from strategic investor Foxconn, along with Fujifilm (TSE:4901), SK Telecom and other private investors, Neve Ilan, Israel-based Nanox said its total funding is now at […]
Zebra Medical Vision appoints new CEO, seeks to grow in U.S.
Zebra Medical Vision announced that it appointed Ohad Arazi as its new CEO as the company as it looks to expand its footprint in the U.S. Arazi’s appointment is set to be made effective on March 1, 2020, at which point he will succeed Zebra co-founder Eyal Gura, who will continue as board chairman. Arazi […]
Synaptive Medical updates Modus V surgical microscope
Synaptive Medical announced that its U.S. and Canadian Modus V robotic digital microscope now includes updates such as additional 3D visualization and voice-activated control. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex cranial procedures. The Modus V provides […]
Philips issues urgent field safety notice for CombiDiagnost R90
Updated with a clarification from Philips. Royal Philips (NYSE:PHG) issued an urgent field safety notice to warn users of an issue with its CombiDiagnost R90 GCF fluoroscopy system. The imaging device used in radiography has shown an error issue when the table-tilting features are used. When using the “Table Up/Down” button on the device, Error 80, […]
3Derm lands FDA breakthrough device designations for autonomous skin cancer AI
3Derm Systems announced that it won two FDA breakthrough device designations for its 3DermSpot autonomous artificial intelligence imaging system for detecting skin cancer. The 3DermSpot is an algorithm designed to use AI and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma and basal cell carcinoma. Autonomous AI has the potential to provide […]
PhotoniCare wins FDA nod for imaging tech to spot ear infections
PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more. The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence […]
CES 2020: Medical technologies you need to know
The mobile health devices and wearables trend is seemingly accelerating this year, with 546 digital health and 635 wearable devices being touted at the annual CES show in Las Vegas. Digital health devices and wearables on display are up from the 505 and 620 devices, respectively, presented at CES 2019. Health and medical devices being […]
Proton therapy lowers risk of side effects for cancer patients, study says
Findings from a new study claim that proton therapy leads to a significantly lower risk of side effects severe enough to lead to unplanned hospitalizations for cancer patients when compared to traditional radiation. Although cure rates between the proton therapy and radiation groups remain almost identical, the study conducted at the Perelman School of Medicine […]
Augmedics launches its Xvision Spine AR nav system in U.S.
Augmedics announced today that it won FDA 510(k) clearance for and initiated the U.S. launch of its Xvision Spine augmented reality guidance system to be used in surgery. The company is touting Xvision Spine as the first AR guidance system to be used in surgery. The system is designed to allow surgeons to visualize the […]
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