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News tagged with “fda clearance”. Found: 46 tagged news reports.
 

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Kalamazoo :: MI :: USA | 16 days 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 | 1 month 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 | 2 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 | 4 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 | 5 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 | 5 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 | 6 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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Rishon Le Zion :: Israel | 8 months ago

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US Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation PillCam, SB 3, which detects and monitors small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal (GI) bleeding and iron deficiency

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New York City :: NY :: USA | 8 months ago

Credibility Credibility of 5

Food and Drug Administration 510(k) clearance for Converged Health Management, a cloud-based, remote patient-monitoring medical device.  This marks the first time Verizon has sought and gained FDA clearance for a healthcare solution. G LTE wireless

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

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It employs Philips' proprietary ClarityIQ technology, which consists of a multitude of software and hardware improvements that combine high quality imaging with low X-ray dose. According to Philips, radiation dose is decreased up to 73% in

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