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Fujifilm Launches Multi-Use Radiography Fluoroscopy System

FUJIFILM Medical Systems U.S.A., Inc., a provider of diagnostic imaging and medical informatics solutions, has launched the Persona RF PREMIUM in the United States.

FDA Issues New Draft Guidance on Remanufacturing of Medical Devices and Discussion Paper on Cybersecurity and Servicing

Many medical devices are reusable and need maintenance and repair. Servicing of devices is critical to their safe and effective use. The U.S. Food and Drug Administration (FDA) has issued two documents as part of its ongoing efforts to help distinguish between...

KA Imaging Inks Deal with BeyMed in Malaysia

KA Imaging has entered into a distribution agreement with BeyMed for distribution of KA imaging innovative dual-energy imaging solution Reveal 35C in the Malaysian market. “KA Imaging is excited to be growing rapidly and providing innovative diagnostic imaging...

POCUS Images Need to be Stored Properly to Avoid Fines

Ultrasound is the fastest growing imaging modality in U.S health care, driving sufficient ubiquity in point-of-care ultrasound (POCUS) that major medical societies are formally examining the implications of its rapid increase.

Qure.ai qER

Imaging Artificial Intelligence (AI) provider Qure.ai announced its first FDA 510(k) clearance for its head CT scan product qER. The FDA’s decision covers four critical abnormalities identified by Qure.ai’s emergency room product. Now the AI tool can be used to triage radiology scans with intracranial bleeds, mass effect, midline shift and cranial fractures. Two of these capabilities – cranial fractures and midline shift – are exclusive to Qure.ai’s product. This means that the newly cleared qER suite will be able to triage nearly all critical abnormalities visible on routine head CT scans. The qER suite plugs directly into the radiology workflow and prioritizes critical cases on the worklist. This triage drastically reduces the time taken to open critical scans, so those with time-sensitive abnormalities get to be read and reported faster, leading to better patient outcomes.

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