Search Results for 'clearance'
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Digital Health
Fourth FDA Clearance Awarded to Zebra Medical for Medical Imaging AI
Company's newest solution automatically identifies findings suggestive of pleural effusion based on CR, DR, and/or DX scans.Business Wire 01.22.20
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Cardiovascular | Diagnostics
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TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System
Company receives clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy procedures.Business Wire 07.10.18
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Mauna Kea Obtains FDA Clearance for Applications of Cellvizio Confocal Laser Endomicroscopy
Product provides unique response to unmet needs during brain and spinal surgeries.Business Wire 07.09.18
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Northeast Scientific Receives FDA 510K Clearance on Reprocessed RF Stylet
Clearance gives the company the green light to reprocess and market the stylet.Globe Newswire 05.02.18
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Contrast Clearance Analysis Software Receives FDA 510(k) Clearance
Scientists evaluate MR-based technology for differentiating treatment effects.Businesswire 01.05.18
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Surgical
Scopis Receives FDA 510(K), Health Canada MDL Clearance for Surgical Navigation System
Company also hires vice president of sales for North America.Business Wire 03.09.17
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Amedica Earns Brazilian Clearance for Silicon Nitride Products
Green light is for Valeo silicon nitride interbody fusion devices and instrument sets.08.13.15
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Cardiovascular | Testing
FDA Grants De Novo Clearance to HeartFlow Imaging System
HeartFlow Inc. has received de novo clearance from the U.S. Food and Drug Administration for its FFRCT technology, a non-invasive imaging technique for coronary artery disease that provides doctors with insight on both the extent of the blockage as w…04.08.15
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Materials
Promoting Medical Devices Prior to FDA Approval or Clearance
Promoting Medical Devices Prior to FDA Approval or Clearance James R. Ravitz, Arent Fox PLLC Earlier this year, this column examined the FDA’s regulations and trends with respect to direct-to-consumer advertising. Now we’ll exam…James R. Ravitz 10.21.06
