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News tagged with “fda clearance”. Found: 49 tagged news reports.
 

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Cleveland :: OH :: USA | 24 days ago

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CT/MRI imaging for use in brain surgery to receive FDA clearance. It enables surgeons to perform a real-life "fly through" of a "patient-specific" surgery and receive unique virtual-reality guidance to determine the safest and most efficient pathway

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Newark :: NJ :: USA | 3 months ago

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Slip op. at 7.   There is one significant difference from the cases we dealt with 15-20 years ago.   Pursuant to the Agency's authority that we previously discussed here , the FDA required a warning specifically about off-label use: The safety and

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El Granada :: CA :: USA | 3 months ago

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The floor mounted system was designed for tight-budgeted facilities looking for a compact general purpose X-ray system. It features a 14 x 17 inch digital detector and can be used on adults, and by removing the system's grid the radiation dose can be

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Kalamazoo :: MI :: USA | 4 months ago

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Ablative Solutions, Inc., a privately-held clinical stage company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Peregrine System(TM) Infusion Catheter.

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El Granada :: CA :: USA | 5 months ago

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In the hospital this usually means intravenous administration, however in other situations this may not always be the most practical solution. Rectal delivery is an alternative that ensures quick and effective absorption. Hospi Corporation  has

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El Granada :: CA :: USA | 5 months ago

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First is the MotionWatch 8, a small and light-weight waterproof wrist-worn device that uses a digital tri-axial accelerometer to monitor patient activity, similarly to many consumer fitness trackers...Accompanying software converts the data into

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El Granada :: CA :: USA | 8 months ago

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NEC MD242C2 24 Diagnostic Display Receives FDA Clearance by Editors on Dec 9, 2013 3:39 pm NEC received FDA approval for its 24-inch MultiSync MD242C2 display to be used for clinical diagnostics...The monitor can be made to automatically dim itself

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Southlake :: TX :: USA | 8 months ago

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ThermiAesthetics, creator of the ThermiRF temperature controlled radio frequency system, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for dermatological and general surgical applications in soft tissue and nerves.

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El Granada :: CA :: USA | 9 months ago

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The device continuously measures hemoglobin (Hb), peripheral oxygen saturation of Hb (SpO2), and it also has low perfusion oximetry, pulse rate, and plethysmography (contraction of the thumb along to the heartbeat). Alarms can be set to warn

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Minneapolis :: MN :: USA | 9 months ago

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The highly accurate and reliable Model 3230 is one of the first medical devices to incorporate Bluetooth ® Smart (low energy) wireless technology. Bluetooth Smart helps to facilitate simple and secure connections to Bluetooth Smart-ready devices for

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